Field Safety Notices: 9 to 13 September 2024
List of Field Safety Notices from 9 to 13 September 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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott: Afinion 2
19 May 2023
MHRA reference: 31845652 2023/009/004/601/050
Agfa HealthCare NV: Enterprise Imaging XERO Viewer
September 2024
MHRA reference: 31859890 2024/009/009/601/019
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: 31848393 2023/007/004/601/015
MHRA reference: 31848393 2023/007/004/601/015 (Acknowledgement)
Biosense Webster: VARIPULSE™ Bi-Directional Catheter
26 April 2024
Cardiac irreversible electroporation system catheter
MHRA reference: 31867911 2024/005/007/601/069
Boston Scientific: EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD
13 September 2023
Single Chamber Implantable Defibrillator
Model: Model A209 - A219
MHRA reference: 31844620 2023/009/013/601/067
CODAN ARGUS: ARGUS 717V
September 2024
General purpose infusion pump
MHRA reference: 31808419 2024/008/026/601/016
MHRA reference: 31808419 2024/008/026/601/016 (Customer reply form)
Emboflu: SQUID / SQUIDPERI
23 July 2024
Embolization implant kit
Model: See attachments
MHRA reference: 31831954 2024/009/009/601/020
GE Healthcare: Centricity PACS System
6 September 2024
Picture archiving and communication system
MHRA reference: 31814656 2024/009/006/601/054
GE HealthCare: Centricity PACS; Centricity Universal Viewer
October 2023
MHRA reference: 31841514 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: 31841801 2023/009/019/601/046
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: 31876559 2024/009/011/601/067 (Customer letter)
MHRA reference: 31876559 2024/009/011/601/067 (Reply form)
Illumina: NextSeq 550Dx / MiSeq Dx / NovaSeq 6000Dx
8 May 2024
Nucleic acid sequence analyser IVD, NGS
MHRA reference: 31814691 2024/005/006/601/079
Implantcast: IFU / OPT: MUTARS® RS stems and extension pieces
13 May 2024
Model: 09300015, MURSSTxx, 67300025, 67300125, 67611220, 67611220N, 67622514, 67621512, 67622012, 67622515
MHRA reference: 31831899 2024/005/016/601/010
JRI Orthopaedics Limited: Evolution Rasps
23 August 2024
MHRA reference: 31815462 2024/008/027/601/014
Merit Medical: MONARCH® Inflation
23 August 2024
MHRA reference: 31814402 2024/009/004/601/031
Oxylitre Holdings Limited: Standard Pressure Regulators
August 2023
Non-fixed medical gas cylinder regulator
Model: R16 Series
MHRA reference: 31840218 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: 31845530 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: 31855156 2024/009/002/601/046
Reison Medical: Tube Holder
CC-23-014
Model: 10-611
MHRA reference: 31841374 2023/009/004/601/022
Siemens Healthcare: Atellica DCA Analyzer and ACR Reagent Kit
March 2023
See general comments - GMDN 56680 and GMDN 62751
MHRA reference: 31842976 2023/003/016/601/002
MHRA reference: 31842976 2023/003/016/601/002 (letter)
Siemens Healthineers: Atellica DCA Analyzer and ACR Reagent Kit
March 2023
See general comments
MHRA reference: 31854788 2023/003/016/601/002
SLE Ltd: SLE6000 Infant Ventilator
24 June 2024
SLE6000 ventilator
Model: SLE6000
MHRA reference: 31844091 2024/006/014/601/058
Smiths Medical: Portex™ Blue Line Siliconised PVC Tracheotomy Tube
9 September 2024
Tracheostomy tube, non-reinforced, non-customized
Model: See FSN
MHRA reference: 31842702 2024/004/011/601/037
Terumo: Spectra Optia Apheresis System
June 2024
MHRA reference: 31833460 2024/006/006/601/049
Tosoh Europe: AIA-PACK MULTI ANALYTE CONTROL
5 September 2023
MHRA reference: 31842892 2023/009/001/601/029
Vygon: DOLPHIN inflation device
5 September 2023
Catheter-balloon inflator, single-use
MHRA reference: 31859864 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: 31842340
Werfen: ACL TOP 700/750-CTS-LAS /300/350/500/550 CTS 970CL
11 August 2023
Coagulation analyser IVD, laboratory
MHRA reference: 31842691 2021/010/022/701/067
ZimVie: Polished Finned 1 Piece Tibial Tray 83 mm
22 September 2023
MHRA reference: 31844718 2023/009/022/601/022