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 the latest FSNs

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Beckman Coulter: DxA 5000 Automation System

12 June 2023

Specimen processing instrument IVD, automated

MHRA reference: 5323189

bioMérieux: MYLA V4.8 SOFTWARE; MYLA V4.9 SOFTWARE

15 February 2023

Laboratory instrument/analyser application software

MHRA reference: 5319742

HS DOMS GmbH: HS 810

28 March 2023

MHRA reference: 5314023

Integra: Surgimend / Primatrix

30 May 2023

Extra-gynaecological surgical mesh/Collagen Matrix

MHRA reference: 5302965

Intuitive: Tip-Up Fenestrated Grasper

ISIFA2023-02-R

Robotic surgical forceps

Model: 470347-12

MHRA reference: 5314523

Medtronic: Durepair Dura Regeneration Matrix

June 2023

Dura mater graft, bovine

Model: 61100, 61105, 61106, 61110, 61111

MHRA reference: 5319571

OLYMPUS: HF-resection electrode

16 June 2023

Electrodes, Electrosurgical

MHRA reference: 5321616

QIAGEN: NeuMoDx Cartridge

May 2023

MHRA reference: 5314266

Randox: Urea Enzymatic Kinetic Assay

09 June 2023

Urea IVD, kit, enzyme spectrophotometry

MHRA reference: 5314857

Samsung: GM85

FSN-GM85_230228-1

Mobile Digital Batteries X-ray Units

MHRA reference: 5295225

Siemens: Cios Select

May 2023

Mobile X-ray system intended for angiography

Model: 11515088

MHRA reference: 5317142

Stryker: AIRO CT SCANNER

June 2023

MHRA reference: 5317111

Talley: Venturi

QRN1006

Negative pressure wound therapy system

Model: Venturi Compact and Venturi MiNO

MHRA reference: 5323149

Tosoh: GX Assay Kit

03 May 2023

BUFFERS (UNASSIGNABLE), SUPPLEM. REAG

MHRA reference: 5203495

Updates to this page

Published 19 June 2023