Field Safety Notices (FSNs) from 12 to 16 June 2023
List of Field Safety Notices (FSNs) from 12 to 16 June 2023.
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View . FSNs before this date are on the
Beckman Coulter: DxA 5000 Automation System
12 June 2023
Specimen processing instrument IVD, automated
MHRA reference:
bioMérieux: MYLA V4.8 SOFTWARE; MYLA V4.9 SOFTWARE
15 February 2023
Laboratory instrument/analyser application software
MHRA reference:
HS DOMS GmbH: HS 810
28 March 2023
MHRA reference:
Integra: Surgimend / Primatrix
30 May 2023
Extra-gynaecological surgical mesh/Collagen Matrix
MHRA reference:
Intuitive: Tip-Up Fenestrated Grasper
ISIFA2023-02-R
Robotic surgical forceps
Model: 470347-12
MHRA reference:
Medtronic: Durepair Dura Regeneration Matrix
June 2023
Dura mater graft, bovine
Model: 61100, 61105, 61106, 61110, 61111
MHRA reference:
Olympus Medical Systems Corporation : BF-Series Endoscopes
13 June 2023
Flexible video bronchoscope, reusable
Model: BF-1TH1100, BF-1TH1200, BF-1T150, BF-1T180, BF-1T260, BF-1T60, BF-1TH190, BF-1TQ170, BF-1TQ180, BF-1TQ290, BF-260, BF-6C260, BF-F260, BF-H1100, BF-H1200, BF-H190, BF-H290, BF-MP60, BF-P150, BF-P180, BF-P260F, BF-P60, BF-PE2, BF-Q170, BF-Q180, BF-Q180-AC, BF-Q190, BF-Q290, BF-TE2, BF-XT160, BF-XT190, BF-XT40
MHRA reference: Â 2025/010/017/601/071
OLYMPUS: HF-resection electrode
16 June 2023
Electrodes, Electrosurgical
MHRA reference:
QIAGEN: NeuMoDx Cartridge
May 2023
MHRA reference:
Randox: Urea Enzymatic Kinetic Assay
09 June 2023
Urea IVD, kit, enzyme spectrophotometry
MHRA reference:
Samsung: GM85
FSN-GM85_230228-1
Mobile Digital Batteries X-ray Units
MHRA reference:
Siemens: Cios Select
May 2023
Mobile X-ray system intended for angiography
Model: 11515088
MHRA reference:
Stryker: AIRO CT SCANNER
June 2023
MHRA reference:
Talley: Venturi
QRN1006
Negative pressure wound therapy system
Model: Venturi Compact and Venturi MiNO
MHRA reference:
Tosoh: GX Assay Kit
03 May 2023
BUFFERS (UNASSIGNABLE), SUPPLEM. REAG
MHRA reference: