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
19th 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)
26th 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)
BALT EXTRUSION SAS: FARGO / CRISTAL BALLOON
26th July 2023
Model: FRG6F115_8MP / CBV18X40/110
MHRA reference: 31845020 2023/009/006/601/008
Belmont Medical Technologies: Belmont Rapid Infuser, RI-2 1000 ml/min,750 ml/min
24th February 2024
Infusion pump, high-flow, warming
Model: 903-00037A and 903-00039A
MHRA reference: 31844932 2023/002/023/601/032
Biocomposites Ltd: GeneX DS 2.5cc and GeneX DS 5cc
29th August 2023
MHRA reference: 31855155 2023/008/029/601/019
Biosense Webster: VARIPULSE™ Bi-Directional Catheter
26th 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
13th September 2023
Single Chamber Implantable Defibrillator
Model: Model A209 - A219
MHRA reference: 31844620 2023/009/013/601/067
Brandon Medical : Quasar eLite
27th February 2023
Operating light & Operating light system
Model: Various
MHRA reference: 31841136 2023/002/028/601/044
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
23rd July 2024
Embolization implant kit
Model: See attachments
MHRA reference: 31831954 2024/009/009/601/020
Exmoor: Exmoor
20th March 2023
Intranasal splint, non-biodegradable
Model: Nasal Splints
MHRA reference: 31845706 2023/003/028/601/038
Fresenius Medical Care: Stay safe Disinfection Cap
25th September 2023
Vascular catheter protective cap
MHRA reference: 31856516 2023/010/002/601/040
GE Healthcare: Centricity PACS System
6th 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
13th 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)
29th 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
8th 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
13th 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
23rd August 2024
MHRA reference: 31815462 2024/008/027/601/014
Löwenstein Medical: LUISA, TIVAN LS, Life One (LM150TD) series
May 2023
MHRA reference: 31846819 2023/009/004/601/013
Masimo: TC-I Reusable Tip Clip Sensor
June 2023
Model: 1895, 2503, and 4053
MHRA reference: 31841425
Medex: Qitexio – 20ml Luer Lock Syringe
28th February 2023
General purpose syringe, single-use
MHRA reference: 31846792 2023/009/005/601/044
Medicina: Medicina ENFit enteral, single use & reusable oral
15th June 2022
Model: LHE01LD, LHE25LD, LHE05, OT005, OT01, OT25, OT05, OTH01, OTH25, OTH05
MHRA reference: 31843630 2023/006/022/601/044
Medline: Hudson RCI® AQUAPAK® Humidifier Adaptors
FSN 23-08
Hudson RCI® AQUAPAK® Humidifier Adaptors
Model: < Add model (normal style)>
MHRA reference: 31841420 2023/008/031/601/077
Medtronic: Hugo™ RAS Arm Cart Assembly Hugo™ RAS Tower
August 2023
MHRA reference: 31841489 2023/008/029/601/068
Merit Medical: MONARCH® Inflation
23rd August 2024
MHRA reference: 31814402 2024/009/004/601/031
Nouvag: Control unit Dispenser DP 30
3rd July 2024
Bedside infusion pump, single-channel
Model: 4180, 4187
MHRA reference: 31839942 2023/009/008/601/055
One Lambda: C1qScreen
7th September 2023
HLA class I & II antibody screening IVD, kit,
MHRA reference: 31844724 2023/010/002/601/067
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
5th 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
23rd 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
Promedics: Promedics
22nd August 2023
Wrist and hand orthosis
Model: WTE
MHRA reference: 31839987 2023/008/025/601/037
Reison Medical: Tube Holder
CC-23-014
Model: 10-611
MHRA reference: 31841374 2023/009/004/601/022
Roche: Please see tables in comments section.
SB_RDC_2023_02
GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENT
MHRA reference: 31841104
MHRA reference: 31841104
MHRA reference: 31841104
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
24th June 2024
SLE6000 ventilator
Model: SLE6000
MHRA reference: 31844091 2024/006/014/601/058
Smiths Medical: Portex™ Blue Line Siliconised PVC Tracheotomy Tube
9th 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
5th September 2023
MHRA reference: 31842892 2023/009/001/601/029
Vygon: DOLPHIN inflation device
5th 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
22nd September 2023
MHRA reference: 31844718 2023/009/022/601/022