188体育

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 . FSNs before this date are on the

Abbott: Afinion 2

19 May 2023

MHRA reference: 听听 2023/009/004/601/050

Agfa HealthCare NV: Enterprise Imaging XERO Viewer

September 2024

MHRA reference: 听听聽 2024/009/009/601/019聽

Agilent: Please see comments (section 8)

26 June 2023

MLH2 antigen IVD; MSH6 antigen IVD; PMS2 IVD

Model: GA08561-2, GA08661-2, GA08761-2

MHRA reference: 听听聽 2023/007/004/601/015

MHRA reference: 听听聽 2023/007/004/601/015 (Acknowledgement)

Biosense Webster: VARIPULSE鈩� Bi-Directional Catheter

26 April 2024

Cardiac irreversible electroporation system catheter

MHRA reference: 听听听听 2024/005/007/601/069

Boston Scientific: EMBLEM鈩� S-ICD and EMBLEM鈩� MRI S-ICD

13 September 2023

Single Chamber Implantable Defibrillator

Model: Model A209 - A219

MHRA reference: 听听聽 2023/009/013/601/067聽

CODAN ARGUS: ARGUS 717V

September 2024

General purpose infusion pump

MHRA reference: 听听听听 2024/008/026/601/016

MHRA reference: 听听听听 2024/008/026/601/016 (Customer reply form)

Emboflu: SQUID / SQUIDPERI

23 July 2024

Embolization implant kit

Model: See attachments

MHRA reference: 听听听听 2024/009/009/601/020

GE Healthcare: Centricity PACS System

6 September 2024

Picture archiving and communication system

MHRA reference: 听听聽 2024/009/006/601/054

GE HealthCare: Centricity PACS; Centricity Universal Viewer

October 2023

MHRA reference: 听听聽 2023/010/002/601/061

Getinge: MAQUET ACROBAT-i Vacuum Stabilizer System

13 September 2023

ACROBAT-i Vacuum Stabilizer System

Model: OM-10000Z

MHRA reference: 听听听听 2023/009/019/601/046聽

Getinge: MEERA operating table (see 8. Comments)

29 August 2024

Universal operating table, electrohydraulic

Model: 720001B0; 720001B2; 720001F0; 720001F2; 710001B0; 710001B2; 700001B0; 700001F0

MHRA reference: 听听 2024/009/011/601/067 (Customer letter)

MHRA reference: 听听 2024/009/011/601/067 (Reply form)聽

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

8 May 2024

Nucleic acid sequence analyser IVD, NGS

MHRA reference: 听听聽 2024/005/006/601/079

Implantcast: IFU / OPT: MUTARS庐 RS stems and extension pieces

13 May 2024

Model: 09300015, MURSSTxx, 67300025, 67300125, 67611220, 67611220N, 67622514, 67621512, 67622012, 67622515

MHRA reference: 听听聽 2024/005/016/601/010

JRI Orthopaedics Limited: Evolution Rasps

23 August 2024

MHRA reference: 听听聽 2024/008/027/601/014

Merit Medical: MONARCH庐 Inflation

23 August 2024

MHRA reference: 听听聽 2024/009/004/601/031

Oxylitre Holdings Limited: Standard Pressure Regulators

August 2023

Non-fixed medical gas cylinder regulator

Model: R16 Series

MHRA reference: 听听听听 2023/008/031/601/035

Permobil: Smartdrive MX2+with Pushtracker E2/E3

5 May 2023

Wheelchair electric-motor-driven propulsion system

Model: MX2+

MHRA reference: 听听听听 2023/005/008/601/045

Philips: Evolution Upgrade 3.0T, Ingenia 1.5T, Ingenia 3.0T

23 August 2024

Magnetic Resonance Imaging (MRI) unit

Model: 781260, 781270, 781358, 781359, 782101, 782103, 782105, 782106, 782107, 782108, 782109, 782110, 782112, 782113, 782115, 782117, 782118, 782119, 782120, 782129, 782133, 782136, 782140, 782143, 782150, 782151

MHRA reference: 听听听听 2024/009/002/601/046

Reison Medical: Tube Holder

CC-23-014

Model: 10-611

MHRA reference: 听2023/009/004/601/022听听听听听

Siemens Healthcare: Atellica DCA Analyzer and ACR Reagent Kit

March 2023

See general comments - GMDN 56680 and GMDN 62751

MHRA reference: 听听聽 2023/003/016/601/002

MHRA reference: 听听聽 2023/003/016/601/002 (letter)

Siemens Healthineers: Atellica DCA Analyzer and ACR Reagent Kit

March 2023

See general comments

MHRA reference: 听听聽 2023/003/016/601/002

SLE Ltd: SLE6000 Infant Ventilator

24 June 2024

SLE6000 ventilator

Model: SLE6000

MHRA reference: 听听听听 2024/006/014/601/058聽

Smiths Medical: Portex鈩� Blue Line Siliconised PVC Tracheotomy Tube

9 September 2024

Tracheostomy tube, non-reinforced, non-customized

Model: See

MHRA reference: 听听听听 2024/004/011/601/037

Terumo: Spectra Optia Apheresis System聽

June 2024

MHRA reference: 听听听听 2024/006/006/601/049

Tosoh Europe: AIA-PACK MULTI ANALYTE CONTROL

5 September 2023

MHRA reference: 听听听听聽 2023/009/001/601/029

Vygon: DOLPHIN inflation device

5 September 2023

Catheter-balloon inflator, single-use

MHRA reference: 听听聽 2023/009/007/601/049

Werfen: ACL TOP 700/750-CTS-LAS /300/350/500/550 CTS 970CL

August 2023

Model: ACL TOP, ACL TOP CTS, ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS ACL TOP 750, ACL TOP 750 CTS, ACL TOP 750 LAS, ACL TOP 550 CTS, ACL TOP 350 CTS

MHRA reference: 听听

Werfen: ACL TOP 700/750-CTS-LAS /300/350/500/550 CTS 970CL

11 August 2023

Coagulation analyser IVD, laboratory

MHRA reference: 听听聽 2021/010/022/701/067

ZimVie: Polished Finned 1 Piece Tibial Tray 83 mm

22 September 2023

MHRA reference: 听听听听2023/009/022/601/022