Field Safety Notices (FSNs) from 5 to 9 June 2023

List of Field Safety Notices (FSNs) from 5 to 9 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

Altomed: Damato Ruthenium Plaque Template

26 May 2023

Eye brachytherapy plaque-/applicator-positioning

Model: A7075CIB, A7075CIA, A7075COC

MHRA reference: 5296456

Baxter: Allen Advance Chest Support w/pad

06 June 2023

Surgical positioning spine board

MHRA reference: 5302171

Beckman Coulter: DxI 9000 Access Immunoassay Analyzer

31 May 2023

Chemiluminescent immunoassay analyser IVD, automated

MHRA reference: 5300761

bioMérieux: EBV R-GENE - BK Virus R-GENE

05 June 2023

MHRA reference: 5296460

Click Medical: RevoLock Align Kits and RevoLock 4-Hole Kits

22 May 2023

Model: threaded insert and snap

MHRA reference: 5296424

Macopharma: Single or multiple blood bag with LCRD2 filter

02 June 2023

In-line red cell filtration system

MHRA reference: 5301297

Medical Innovation Development: Medical Innovation Development / MIDBAND

05 May 2023

Gastric Band

Model: Adjustable Gastric Band

MHRA reference: 5240834

Medtronic: Vanta with AdaptiveStim Technology

FA1340 June 2023

Spinal cord/peripheral nerve implantable analgesic

Model: 977006

MHRA reference: 5301164

Medtronic: Cytosponge Cell Collection Device

June 2023

Cytology Scraper, single use

Model: CYTO-201

MHRA reference: 5296419

Philips: Azurion, Allura Xper

12 June 2023

Interventional Fluoroscopic X-Ray System

Model: 722010, 722012, 722022, 722023, 722026, 722028, 722033, 722035, 722079, 722224

MHRA reference: 5303178

Philips: HeartStart Intrepid Monitor/Defibrillator

16 May 2023

Defibrillators

Model: 867172

MHRA reference: 5303186

Poly Medicure: Polyflush Syringe, 0.9% Sodium chloride (0.9% NaCl), (Saline Solution Pre-Filled Syringes Single Sterile)

18 May 2023

MHRA reference: 5302580

Therapy Equipment: 0-15LPM Diamond Flowmeter

FSCA 2022-1_9505 Diamond Flowmeter

Diamond Flowmeter

Model: 9505

MHRA reference: 5005603

Thermo Fisher Scientific: Bilirubin Total (DCA)

01 June 2023

Total bilirubin IVD, kit, spectrophotometry

MHRA reference: 5296426

Thermo Fisher Scientific: RapID STR System

02 June 2023

MHRA reference: 5296441

23 April 2023

MHRA reference: 5303214

Updates to this page

Published 13 June 2023