Field Safety Notices: 6 to 10 May 2024

List of Field Safety Notices from 6 to 10 May 2024.

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

Abbott: HeartMate System Monitor 

May 2024

Implantable ventricular circulatory assist system 

Model: L1286INT, 1286INT, L1286A, L1286, 1286A, 1286 

MHRA reference: 30444212    

Alcon: Ophthalmic knives 

03 May 2024

Ophthalmic knife, single-use

MHRA reference: 30435154    

B Braun: AESCULAP AEOS 

03 May 2024

Neurosurgical microscope 

Model: PV010 

MHRA reference: 30356790    

Bio-Rad: GENIE FAST HIV ½ 

02 May 2024

HIV1/HIV2 antibody IVD, kit, immunochromatographic 

MHRA reference: 30362391   

BVI: Beaver 378227  Xstar Safety Slit Knife, 2.75 mm

10 May 2024

Ophthalmic knife, single-use 

Model: 378227 

MHRA reference: 30448074    

EOS imaging: oneFIT Total Knee PSI

NCR-2023-0068

Joint prosthesis implantation kit, single-use 

MHRA reference: 30441331    

GE Healthcare: MyoSPECT - MyoSPECT ES

Ref. # 40906

Stationary gamma camera system

MHRA reference: 30362385    

Illumina: NextSeq 550Dx / MiSeq Dx / NovaSeq 6000Dx 

08 May 2024

Nucleic acid sequence analyser IVD, NGS 

MHRA reference: 30356810    

30 April 2024

Uncoated knee femur prosthesis  

Model: 15-8542/02; 15-8542/04  

MHRA reference: 30357037     

Medicina: Feeding and Aspiration Tubes 

07 May 2024

Model: LG -NGP - NJP – RT – ST – EF2EL 

MHRA reference: 30438813    

Medtronic: Various Implantable Cardioverter Defibrillators (ICDs) 

May 2024 FA1416

MHRA reference: 30446864     

Philips: Incisive CT/CT3500/CT5300 

15 April 2024

Full-body CT system 

Model: 728143,728144,728146,728148,728149,728151, 728134, 728138, 728139, 728285 

MHRA reference: 30446934    

Stryker: EXETER 2.5 I M PLUG

01 May 2024

MHRA reference: 30438814     

The Binding Site: EXENT analyser 

05 April 2024

Mass spectrometry analyser IVD 

MHRA reference: 30356793  

Updates to this page

Published 13 May 2024