tag:www.gov.uk,2005:/drug-device-alertsAlerts, recalls and safety information: medicines and medical devices for Device safety information2026-01-15T14:00:17+00:00HM Governmenttag:www.gov.uk,2005:/drug-device-alerts/m6-c-artificial-cervical-disc-spinal-kinetics-llc-new-monitoring-requirements-for-the-risk-of-osteolysis2026-01-15T14:00:17+00:00M6-C Artificial Cervical Disc, Spinal Kinetics LLC: New monitoring requirements for the risk of osteolysis (DSI/2026/001)The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is issuing new monitoring requirements for patients implanted with the M6-C artificial cervical disc.tag:www.gov.uk,2005:/drug-device-alerts/bd-bodycomm-version-3-dot-3-software-used-for-bodyguard-infusion-pumps-bodyguard-t-and-t34-syringe-drivers-important-steps-to-manage-transition-to-windows-11-dsi-slash-2025-slash-0062025-10-06T14:03:14+01:00BD BodyComm™ version 3.3 software used for BodyGuard infusion pumps, BodyGuard-T and T34 syringe drivers: Important steps to manage transition to Windows 11 (DSI/2025/006)The BodyComm software currently uses Windows 10. Microsoft is transitioning to Windows 11 from 14 October 2025 which requires an updated cable to connect the pumps to the BodyComm software. These cables may not be available …tag:www.gov.uk,2005:/drug-device-alerts/profemur-cobalt-chrome-modular-neck-hip-replacements-higher-than-anticipated-risk-of-revision-surgery-metal-wear-effects-and-component-fracture-dsi-slash-2025-slash-0052025-09-04T10:07:02+01:00Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem compone…tag:www.gov.uk,2005:/drug-device-alerts/updated-guidance-on-the-management-of-the-recalled-endologix-nellix-endovascular-aneurysm-sealing-evas-system-dsi-slash-2025-slash-0042025-07-28T14:06:56+01:00Updated guidance on the management of the recalled Endologix Nellix EndoVascular Aneurysm Sealing (EVAS) System (DSI/2025/004)The MHRA provides an update to previous guidance on the management of patients treated with the recalled Endologix Nellix EVAS System to reflect revised recommendations. All implanted patients in the UK with this device shou…tag:www.gov.uk,2005:/drug-device-alerts/trinity-biotech-premier-hb9210-hba1c-analyser-risk-of-positive-bias-and-updates-to-instructions-for-use-ifu-including-use-as-a-diagnostic-aid-in-diabetes-mellitus-dsi-slash-2025-slash-0032025-07-22T14:21:49+01:00Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus (DSI/2025/003)The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic…tag:www.gov.uk,2005:/drug-device-alerts/aurum-pre-filled-syringes-phased-introduction-of-new-10ml-connect-syringe-barrel-importance-of-selecting-compatible-needle-free-connectors-to-minimise-the-risk-of-syringe-blockage-dsi-slash-2025-slash-022025-07-01T11:31:46+01:00Aurum pre-filled syringes phased introduction of new 10ml CONNECT syringe barrel: Importance of selecting compatible needle-free connectors to minimise the risk of syringe blockage (DSI/2025/02)Due to a phased introduction of the new 10ml CONNECT barrel design for the Aurum pre-filled syringes, the range of compatible needle free connectors (NFCs) differs between the established syringe barrel and the new syringe b…tag:www.gov.uk,2005:/drug-device-alerts/philips-respironics-bipap-a-series-ventilators-alarm-malfunction-and-risk-of-therapy-interruptions-in-ventilators-not-intended-for-life-support-dsi-slash-2024-slash-0062025-05-23T14:47:57+01:00Philips Respironics BiPAP A series ventilators: alarm malfunction and risk of therapy interruptions in ventilators not intended for life-support, DSI/2024/006Philips Respironics has issued a Field Safety Notice (FSN) relating to the Bilevel Positive Airway Pressure (BiPAP) A series ventilators. This relates to a Ventilator Inoperative alarm which could result in the potential los…tag:www.gov.uk,2005:/drug-device-alerts/suzhou-surgicare-disposable-hysteroscopy-sheath-recall-due-to-withdrawn-ce-certificate-dsi-slash-2025-slash-0012025-03-19T13:41:31+00:00Suzhou Surgicare disposable Hysteroscopy Sheath– Recall due to withdrawn CE certificate, (DSI/2025/001)The MHRA has become aware of Hysteroscopy Sheaths supplied in the UK market with a withdrawn CE certificate. Healthcare professionals and providers should immediately stop use, quarantine, and stop supply of any identified p…tag:www.gov.uk,2005:/drug-device-alerts/cpt-hip-system-femoral-stem-12-slash-14-neck-taper-increased-risk-of-postoperative-periprosthetic-femoral-fracture-dsi-slash-2024-slash-0072024-09-04T11:02:03+01:00CPT Hip System Femoral Stem 12/14 Neck Taper: Increased Risk of Postoperative Periprosthetic Femoral Fracture, DSI/2024/007Recent research has found that the CPT Hip System Femoral Stem 12/14 Neck Taper, cobalt chromium, (a type of hip implant) carries a higher risk of postoperative periprosthetic femoral fracture (PFF) compared to hips of a sim…tag:www.gov.uk,2005:/drug-device-alerts/symbios-origin-r-posterior-stabilised-patient-matched-total-knee-replacement-device-risk-of-early-revision-dsi-slash-2024-slash-0052024-04-23T11:31:22+01:00Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee Replacement Device: Risk of Early Revision, DSI/2024/005The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement.tag:www.gov.uk,2005:/drug-device-alerts/0-dot-9-percent-sodium-chloride-solutions-for-irrigation-inhalation-and-eyewash-recall-from-manufacturer-legency-remedies-dsi-slash-2024-slash-0042024-04-04T14:02:30+01:000.9% Sodium Chloride Solutions for Irrigation, Inhalation, and Eyewash: recall from manufacturer Legency Remedies, DSI/2024/004Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination.tag:www.gov.uk,2005:/drug-device-alerts/counterfeits-and-unbranded-copies-of-lifevac-anti-choking-devices-may-fail-to-work-correctly-or-worsen-choking-incidents-if-used-dsi-slash-2024-slash-0032024-03-25T11:00:08+00:00Counterfeits and unbranded copies of LifeVac anti-choking devices may fail to work correctly or worsen choking incidents if used, DSI/2024/003Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed.
There are numerous counterfeit and unbranded anti-choking devices being sold in the UK o…tag:www.gov.uk,2005:/drug-device-alerts/magec-x-system-nuvasive-specialized-orthopedics-nso-uk-suspension-lifted-dsi-slash-2024-slash-0022024-03-12T15:12:07+00:00MAGEC X System, NuVasive Specialized Orthopedics (NSO): UK suspension lifted, (DSI/2024/002)The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK.tag:www.gov.uk,2005:/drug-device-alerts/paclitaxel-coated-devices-pcd-used-in-the-treatment-of-peripheral-arterial-disease-update-to-previous-mhra-guidance-on-use-where-indicated-pcd-can-be-considered-as-a-treatment-option-for-both-critical-limb-ischaemia-cli-and-interm2024-02-05T13:37:23+00:00Paclitaxel coated devices (PCD) used in the treatment of peripheral arterial disease: update to previous MHRA guidance on use. Where indicated, PCD can be considered as a treatment option for both critical limb ischaemia (CLI) and intermittent claudication (IC) patients. (DSI/2024/001) Following a review, the MHRA has updated previous guidance (DSI/2022/003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD). tag:www.gov.uk,2005:/drug-device-alerts/specific-brands-of-carbomer-eye-gel-recall-of-aacarb-eye-gel-aacomer-eye-gel-and-puroptics-eye-gel-potential-risk-of-infection-dsi-slash-2023-slash-112023-11-24T11:03:47+00:00Specific brands of carbomer eye gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel: potential risk of infection, DSI/2023/11Specific batches of carbomer gel are being recalled as a precaution due to possible
microbiological contamination.tag:www.gov.uk,2005:/drug-device-alerts/sterifeed-colostrum-collection-device-and-risk-of-choking-due-to-infant-airway-occlusion-dsi-slash-2023-slash-0102023-10-10T14:00:27+01:00SteriFeed Colostrum Collection device and risk of choking due to infant airway occlusion, DSI/2023/010The SteriFeed colostrum collection device is intended to be used only to collect and store colostrum. It should not be used as an infant feeding device as the cap, if not removed, can easily get dislodged and become stuck in…tag:www.gov.uk,2005:/drug-device-alerts/no-react-r-cardiovascular-bioprosthesis-implantables-discontinuation-of-ce-marking-and-manufacture-remaining-stock-may-continue-to-be-used-and-any-adverse-incidents-reported-nationally-dsi-slash-2023-slash-0092023-09-04T14:00:33+01:00No-React® cardiovascular bioprosthesis implantables: discontinuation of CE marking and manufacture. Remaining stock may continue to be used and any adverse incidents reported nationally (DSI/2023/009)The MHRA emphasises the importance of national reporting of any suspected adverse incidents associated with the product following CE certification withdrawal and cease of manufacturing. tag:www.gov.uk,2005:/drug-device-alerts/ethypharm-aurum-pre-filled-syringes-are-incompatible-with-some-manufactured-needle-free-connectors-risk-of-delay-in-administering-potentially-lifesaving-medication-dsi-slash-2023-slash-0082023-08-22T11:51:33+01:00Ethypharm Aurum pre-filled syringes are incompatible with some manufactured needle-free connectors: risk of delay in administering potentially lifesaving medication, DSI/2023/008Attaching an incompatible needle-free connector (NFC) to an Ethypharm Aurum pre-filled syringe can block the syringe and prevent delivery of potentially lifesaving medicine. Only compatible NFCs should be used with pre-fille…tag:www.gov.uk,2005:/drug-device-alerts/eyecee-one-and-eyecee-one-crystal-preloaded-intraocular-lenses-iols-update-of-previous-quarantine-advice-after-identification-of-likely-cause-dsi-slash-2023-slash-0072023-08-03T13:57:50+01:00EyeCee One and EyeCee One Crystal preloaded intraocular lenses (IOLs): update of previous quarantine advice after identification of likely cause, DSI/2023/007The MHRA is providing an update on the issue of increased intraocular pressure in patients implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses.tag:www.gov.uk,2005:/drug-device-alerts/nuvasive-specialized-orthopedics-nso-precice-titanium-systems-uk-suspension-lifted-dsi-2023-slash-0062023-04-12T09:59:41+01:00NuVasive Specialized Orthopedics (NSO) PRECICE Titanium Systems: UK Suspension Lifted, DSI 2023/006The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the PRECICE Titanium subset of devices (Intra-Medullary Limb Lengthening (IMLL), Short, Unyte …tag:www.gov.uk,2005:/drug-device-alerts/belzer-uw-cold-storage-solution-and-belzer-mps-uw-machine-perfusion-solution-manufactured-by-carnamedica-ukrp-bridge-to-life-contamination-of-fluid-update-to-dsi-slash-2023-slash-002-dsi-slash-2023-slash-0052023-04-04T11:02:14+01:00Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica (UKRP: Bridge to Life): Contamination of fluid (update to DSI/2023/002), DSI/2023/005The MHRA is providing an update on defects identified with Belzer solutions, manufactured by Carnamedica (UK Responsible Person Bridge to Life).tag:www.gov.uk,2005:/drug-device-alerts/bd-bodyguard-microsets-and-residual-ethylene-oxide-devices-may-continue-to-be-used-to-treat-paediatric-patients-5kg-and-above-dsi-slash-2023-slash-0042023-02-20T15:55:47+00:00BD BodyGuard MicroSets and residual ethylene oxide: devices may continue to be used to treat paediatric patients 5kg and above, DSI/2023/004As a precautionary measure, following an MHRA assessment of currently available data on EO levels, alternative devices to the BD BodyGuard Microsets should be sought in users of 5kg bodyweight and below.tag:www.gov.uk,2005:/drug-device-alerts/nexgen-knee-replacement-affected-patients-should-be-offered-additional-follow-up2023-02-15T12:43:56+00:00NexGen Knee replacement: affected patients should be offered additional follow up, DSI/2023/003The National Joint Registry (NJR) has identified that both the NexGen® Stemmed Option Tibial Components, when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Fem…tag:www.gov.uk,2005:/drug-device-alerts/belzer-uw-cold-storage-solution-and-belzer-mps-uw-machine-perfusion-solution-manufactured-by-carnamedica-ukrp-bridge-to-life-contamination-of-fluid-dsi-slash-2023-slash-0022023-01-31T15:31:47+00:00Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica (UKRP: Bridge to Life): Contamination of fluid; DSI/2023/002Carnamedica has identified issues with third-party suppliers, which could result in microbiological contamination, particulate matter within the solution, and leakage of fluid.
tag:www.gov.uk,2005:/drug-device-alerts/eyecee-one-preloaded-and-eyecee-one-crystal-preloaded-intraocular-lenses-iols-stop-using-immediately-and-quarantine-all-preloaded-eyecee-one-lenses-dsi-slash-2023-slash-0012023-01-26T09:10:36+00:00EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs): stop using immediately and quarantine all preloaded EyeCee One lenses DSI/2023/001The MHRA is aware of reports of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs).tag:www.gov.uk,2005:/drug-device-alerts/haemodialysis-and-haemofiltration-machines-actions-to-take-following-pressure-related-alarms-to-avoid-unintentional-alteration-of-alarm-limits-dsi-slash-2022-slash-0042022-09-21T16:24:51+01:00Haemodialysis and haemofiltration machines: Actions to take following pressure-related alarms to avoid unintentional alteration of alarm limits DSI/2022/004Venous and arterial pressure limits may be altered unintentionally following acknowledgement of the alarm in some haemodialysis and haemofiltration machines. If the cause of the alarm is not addressed, the machine may not re…tag:www.gov.uk,2005:/drug-device-alerts/paclitaxel-drug-coated-balloons-dcbs-or-drug-eluting-stents-dess-updated-position-on-use-in-patients-with-critical-limb-ischaemia-and-intermittent-claudication-dsi-slash-2022-slash-0032022-04-05T17:08:23+01:00Paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs): Updated position on use in patients with critical limb ischaemia and intermittent claudication DSI/2022/003The MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia.tag:www.gov.uk,2005:/drug-device-alerts/surdial-x-haemodialysis-machine-potential-for-devices-to-remove-excess-fluid-outside-of-machine-specification-dsi-slash-2022-slash-0022022-02-17T13:57:20+00:00Surdial X Haemodialysis machine: potential for devices to remove excess fluid outside of machine specification. DSI/2022/002The MHRA are aware of instances of Surdial X machines removing excess fluid via ultrafiltration outside of its specification. There is a risk to patients who are unable to tolerate excess fluid removal. tag:www.gov.uk,2005:/drug-device-alerts/stop-using-vaginal-speculums-with-smoke-tube-and-gynaecological-hysteroscopy-sheaths-from-gemini-surgical-uk-all-lots-and-batches-dsi-slash-2022-slash-0012022-02-17T13:26:23+00:00Stop using Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK: all lots and batches. DSI/2022/001The MHRA has become aware that Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK are being sold with a falsely applied CE mark. This means that these devices have been sold wit…tag:www.gov.uk,2005:/drug-device-alerts/rheovalves-disposable-needle-free-valves-stop-using-specific-lots-due-to-risk-of-breakage-in-patient-dsi-slash-2021-slash-0102021-12-20T16:02:36+00:00Rheovalves disposable needle-free valves: stop using specific lots due to risk of breakage in patient. DSI/2021/010Baihe Medical have identified an increase in complaints for Rheovalves disposable needle-free valves product code RVNF1. Devices from specific lots are affected. There is a risk of the device breaking in use.
tag:www.gov.uk,2005:/drug-device-alerts/medical-device-alerts-archived-in-december-20212021-12-03T15:20:25+00:00Medical device alerts archived in December 2021Following our latest review of medical device alerts, we have archived the ones listed below.tag:www.gov.uk,2005:/drug-device-alerts/handpieces-used-in-the-phacoemulsification-technique-of-cataract-removal-need-for-careful-cleaning-dsi-slash-2021-slash-0092021-11-24T09:51:01+00:00Handpieces used in the phacoemulsification technique of cataract removal: need for careful cleaning (DSI/2021/009)Residue particles can end up in the patient’s eye.
For the attention of decontamination specialists, theatre practitioners and anyone involved with the cleaning and decontamination of medical devices.tag:www.gov.uk,2005:/drug-device-alerts/medical-device-alerts-archived-in-november-20212021-11-09T11:56:24+00:00Medical device alerts archived in November 2021Following our latest review of medical device alerts, we have archived the ones listed below.tag:www.gov.uk,2005:/drug-device-alerts/medical-device-alerts-archived-in-october-20212021-10-07T10:18:25+01:00Medical device alerts archived in October 2021Following our latest review of medical device alerts, we have archived the ones listed below.tag:www.gov.uk,2005:/drug-device-alerts/medical-device-alerts-archived-in-september-20212021-09-02T12:38:02+01:00Medical device alerts archived in September 2021Following our latest review of medical device alerts, we have archived the ones listed below.tag:www.gov.uk,2005:/drug-device-alerts/medical-devices-sterilised-by-steril-milano-potential-for-incomplete-sterilisation-dsi-slash-2021-slash-0082021-06-29T16:44:44+01:00Medical devices sterilised by Steril Milano – potential for incomplete sterilisation (DSI/2021/008) Fraudulent activity by this third-party sterilisation provider has been identified. Multiple medical device manufacturers are affected. Manufacturers are advising customers of actions required to mitigate risks. tag:www.gov.uk,2005:/drug-device-alerts/recall-of-bd-venflon-pro-safety-iv-cannula2021-05-20T11:14:17+01:00Recall of BD Venflon Pro safety and Venflon Pro IV cannula (DSI/2021/006R)Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port.tag:www.gov.uk,2005:/drug-device-alerts/targeted-communication-ce-mark-suspended-for-all-magec-systems-manufactured-by-nuvasive-specialized-orthopedics-inc2021-05-10T15:51:13+01:00Targeted communication: CE mark suspended for all MAGEC systems manufactured by NuVasive Specialized Orthopedics, Inc. (DSI/2021/007)Recommendations for clinicians including not implanting these devices tag:www.gov.uk,2005:/drug-device-alerts/total-parenteral-tpn-and-enteral-nutrition-bags-manufactured-by-diffuplast-sterilisation-issue2021-04-20T16:55:22+01:00Total parenteral (TPN) and enteral nutrition bags manufactured by Diffuplast: Sterilisation issue (DSI/2021/005)Diffuplast has identified a potential issue with their third-party sterilisation provider. The risk to patients is very low and therefore patients should continue to use their products as normal. tag:www.gov.uk,2005:/drug-device-alerts/dexcom-g6-sensor-untested-barrier-methods-to-reduce-skin-reactions2021-04-06T15:43:48+01:00Dexcom G6 Sensor: untested barrier methods to reduce skin reactions (DSI/2021/004)Users of this continuous glucose monitoring system may experience adverse skin reactions to the sensor. tag:www.gov.uk,2005:/drug-device-alerts/medoject-sterile-hypodermic-and-blunt-fill-needles-manufactured-by-chirana-t-injecta-discontinue-use2021-03-29T15:07:47+01:00Medoject sterile hypodermic and blunt fill needles manufactured by Chirana T. Injecta – discontinue use (DSI/2021/003)There is the potential for a black residue to be present on all Medoject hypodermic and blunt fill needles tag:www.gov.uk,2005:/drug-device-alerts/targeted-letter-implantable-orthopaedic-devices-manufactured-by-implants-international-ltd-trading-as-xtremity-solutions-ltd2021-02-26T15:30:24+00:00Targeted letter: Implantable orthopaedic devices manufactured by Implants International Ltd trading as Xtremity Solutions Ltd. (DSI/2021/002)Unknown risks following distribution of product after CE certificate withdrawaltag:www.gov.uk,2005:/drug-device-alerts/medical-devices-safety-bulletin-mdsb-2020-022020-11-05T14:00:40+00:00Medical Devices Safety Bulletin (MDSB/2020/02)Regular safety information for healthcare professionalstag:www.gov.uk,2005:/drug-device-alerts/medical-devices-safety-bulletin-mdsb-2020-012020-10-19T11:02:29+01:00Medical Devices Safety Bulletin (MDSB/2020/01)This is a new regular bulletin from Medicines and Healthcare products Regulatory Agency (MHRA) to inform health and care professionals of new or ongoing safety issues with medical devices. It is aimed at all parts of the hea…tag:www.gov.uk,2005:/drug-device-alerts/philips-sterilizable-defibrillator-internal-paddles-specific-models-may-fail-to-deliver-therapy-if-pre-use-checks-are-not-followed2020-07-23T13:00:50+01:00Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed (MDA/2020/022)Manufactured by Philips – defibrillator internal paddles may wear over time and might fail to deliver therapy, so it is important to do routine operational checks between each usage.tag:www.gov.uk,2005:/drug-device-alerts/spinal-fixation-system-risk-of-implant-failure-prior-to-completion-of-bone-healing-mda-2020-0202020-07-10T10:30:51+01:00Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020)
Manufactured by Synthes GmbH – cracking of the USS II Polyaxial 3D Head rings may result in loosening of the fixation system prior to completion of bone healing.tag:www.gov.uk,2005:/drug-device-alerts/abbott-trifecta-trifecta-gt-bioprosthetic-aortic-heart-valves-cases-of-structural-valve-deterioration-svd-mda-2020-0192020-07-06T10:45:36+01:00Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019)Manufactured by Abbott – cases of valvular insufficiency and early revision.tag:www.gov.uk,2005:/drug-device-alerts/philips-heartstart-xl-defibrillator-monitor-therapy-selector-switch-may-fail-mda-2020-0182020-06-30T10:00:03+01:00Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)Manufactured by Philips – the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.tag:www.gov.uk,2005:/drug-device-alerts/philips-heartstart-mrx-monitor-defibrillators-may-fail-to-deliver-therapy-without-alerting-the-user-to-a-fault-in-the-event-of-internal-damage-mda-2020-0162020-06-17T14:01:13+01:00Philips HeartStart MRx Monitor/Defibrillators - may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016)The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.tag:www.gov.uk,2005:/drug-device-alerts/results-from-laboratory-based-tests-for-covid-19-antibodies-using-capillary-blood-sample-collection-kits-may-not-be-reliable-mda-2020-0152020-06-08T10:01:28+01:00Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015)This covers issues with both laboratory based tests for COVID-19 antibodies (unvalidated sample type) and capillary blood sample collection kits (unvalidated for home use)