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 . FSNs before this date are on the
Abbott: HeartMate System MonitorÂ
May 2024
Implantable ventricular circulatory assist systemÂ
Model: L1286INT, 1286INT, L1286A, L1286, 1286A, 1286Â
MHRA reference: ÌýÌýÌýÌý
Alcon: Ophthalmic knivesÂ
03 May 2024
Ophthalmic knife, single-use
MHRA reference: ÌýÌýÌýÌý
B Braun: AESCULAP AEOSÂ
03 May 2024
Neurosurgical microscopeÂ
Model: PV010Â
MHRA reference: ÌýÌýÌýÌý
Bio-Rad: GENIE FAST HIV ½Â
02 May 2024
HIV1/HIV2 antibody IVD, kit, immunochromatographicÂ
MHRA reference: ÌýÌýÌý
BVI: Beaver 378227Â Xstar Safety Slit Knife, 2.75 mm
10 May 2024
Ophthalmic knife, single-useÂ
Model: 378227Â
MHRA reference: ÌýÌýÌýÌý
EOS imaging: oneFIT Total Knee PSI
NCR-2023-0068
Joint prosthesis implantation kit, single-useÂ
MHRA reference: ÌýÌýÌýÌý
GE Healthcare: MyoSPECT - MyoSPECT ES
Ref. # 40906
Stationary gamma camera system
MHRA reference: ÌýÌýÌýÌý
Illumina: NextSeq 550Dx / MiSeq Dx / NovaSeq 6000DxÂ
08 May 2024
Nucleic acid sequence analyser IVD, NGSÂ
MHRA reference: ÌýÌýÌýÌý
LINK: Endo-Model EVO -W, Femoral ComponentÂ
30 April 2024
Uncoated knee femur prosthesisÌýÌý
Model: 15-8542/02; 15-8542/04ÌýÌý
MHRA reference: ÌýÌýÌýÌýÂ
Medicina: Feeding and Aspiration TubesÂ
07 May 2024
Model: LG -NGP - NJP â€� RT â€� ST â€� EF2ELÂ
MHRA reference: ÌýÌýÌýÌý
Medtronic: Various Implantable Cardioverter Defibrillators (ICDs)Â
May 2024 FA1416
MHRA reference: ÌýÌý ÌýÌý
Philips: Incisive CT/CT3500/CT5300Â
15 April 2024
Full-body CT systemÂ
Model: 728143,728144,728146,728148,728149,728151, 728134, 728138, 728139, 728285Â
MHRA reference: ÌýÌýÌýÌý
Stryker: EXETER 2.5 I M PLUG
01 May 2024
MHRA reference: ÌýÌýÌýÌýÂ
The Binding Site: EXENT analyserÂ
05 April 2024
Mass spectrometry analyser IVDÂ
MHRA reference: ÌýÌý