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
LINK: Endo-Model EVO -W, Femoral Component
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