Field Safety Notices: 5 to 9 August 2024
List of Field Safety Notices from 5 to 9 August 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
Boston Scientific Corporation: WallFlexTM Esophageal Stent System AgileTM Esophageal Over the Wire (OTW) Stent System
01 August 2024
WallFlex & Agile Esophageal Stent Systems
Polymer-metal oesophageal stent, non-sterile
MHRA reference: 31402807 2024/008/001/601/065
Cook Medical Europe Ltd.: Rabinov Sialography Set, Fanelli Cholangiography Catheter Set, BiWire® Nitinol Core Wire Guide with Hydrophilic Coating
07 August 2024
Reference Part Numbers (RPNs): SCS-P-16-L, C-FCC-100, BW-035150, and BWS-035150
Order Numbers (GPNs): G01346, G12950, G46141, and G46138, respectively
MHRA reference: 31425069 - Customer reply form 2024/008/005/601/055
MHRA reference: 31425069 - Letter
Sysmex Corporation Japan: XF-1600
22 July 2024
Flow cytometry analyser IVD
Model: all
MHRA reference: 31424770 2024/008/005/601/011
Nutricia Medical Devices BV: Flocare Infinity III
02 August 2024
Flocare Infinity III enteral feeding pump
Model: 202320912028 to 202328312208
Concerned EU AC plug heads, LOT- KRAD28H
MHRA reference: 31415195 2024/008/002/601/039
Cookson Precious Metals Ltd: Dental Alloys and Solders
01 August 2024
MHRA reference: 31414685 2024/008/002/601/047
Medtronic: Flexya Dialysis Machine Net Fluid Removal
01 July 2024
Haemodialysis system, institutional
Model: IBN03X700, IBN03X701
MHRA reference: 31401975 - Letter 2024/008/001/601/066
MHRA reference: 31401975 - Customer acknowledgement form
Beckman Coulter, Inc.: Power Express Centrifuge
26 July 2024
Specimen processing instrument IVD, automated
Model: B90918; B36365; B36366
MHRA reference: 31401796 - Letter
MHRA reference: 31401796 – Vigilance response form 2024/008/001/601/035
Philips: Allura Xper R8.1 System with Poly-G Stand
31 July 2024
Stationary general-purpose fluoroscopic x-ray
MHRA reference: 31401972 2024/008/001/601/015
B. Braun Medical Ltd: MONOPLUS
05 August 2024
MONOPLUS VIOLE 1(4)150CM HR48 LOOP(M)DDP
Model: 124243
MHRA reference: 31440080 2024/008/006/601/046
GE HealthCare: Centricity Universal Viewer Zero Footprint client
Medical Image Management System
Model: v6.0 SP9.x and SP10.x
MHRA reference: 31438792 2024/008/006/601/069
Revvity: Prenatal BoBs
06 August 2024
Model: 3100-0020; 3100-002Z (China specific version)
MHRA reference: 31436990 2024/008/006/601/042
Philips: Update FSN - Achieva 1.5T, Achieva 1.5T Conversion, Ingenia 1.5T CX, Intera 1.5T, Intera 1.5T Power/Pulsar, SmartPath to dStream for 1.5T
27 June 2024
Magnetic Resonance Imaging (MRI) unit
Model: 781105, 781195, 781295, 781178, 781196, 781296, 781343, 781283, 781346, 781261, 781262, 781260, 782112
MHRA reference: 31453581 2023/010/025/601/095
Philips: Azurion System R1.x
11 July 2024
Interventional Fluoroscopic X-Ray System
MHRA reference: 31452704 2024/007/015/601/042
Philips: SENSE XL Torso (1.5T and 3.0T) Coils
31 May 2024
Magnetic Resonance Imaging (MRI) unit
MHRA reference: 31452607 2024/006/006/601/057
Beckman Coulter, Inc.: Access HBc Ab Reagent
05 August 2024
Model: 34240 LOT. 494328
MHRA reference: 31445684 - Letter 2024/006/010/601/023
MHRA reference: 31445684 – Vigilance response form
Ossur: Miami J® Select
July 2024
Cervical spine immobilizer/collar
Model: see Appendix A – Impacted Lot Numbers
MHRA reference: 31447119 - Letter 2024/008/007/601/045
MHRA reference: 31447119 – Customer acknowledgement form
Boston Scientific: Vercise Genus™ Implantable Pulse Generator System
08 August 2024
Deep brain electrical stimulation system
Model: DB-1216 and DB-1232
MHRA reference: 31457499 2024/008/008/601/067