Field Safety Notices: 24 to 28 February 2025
List of Field Safety Notices from 24 to 28 February 2025.
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
Advena Ltd: 5F Climber Guiding Catheter
20.02.2025
Rev 1: February 2025
FSN Ref: 25-001
Vascular Guide Catheter
Model: GC-P5EB350N
MHRA reference: 34843619 2025/002/025/601/045
Canon: Canon VL System INFX-8000 s/n 12345678 Ceiling mounted vascular system
26 February 2025
Canon Ref: COM-0000001285
Stationary angiographic x-ray system, digital
Affected systems: INFINIX/CF, INFX-8000C, INFX-8000F, INFX-8000V INFX-8000H
MHRA reference: 34851537 2025/002/026/601/045
FUJIFILM Corporation: FUJIFILM DR-XD1000 (FDR Nano)
February 2025
Reference number: ECN-004823
Mobile basic diagnostic x-ray system, digital
Model: DR-XD 1000
Serial number: The last 4 digits of SN are 2153 or less
MHRA reference: 34802606 2025/002/021/601/031
Medtronic: Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff Reusable Inner Cannula
27th February 2025
Medtronic Reference: FA1480
Tracheostomy tube, non-reinforced, non-customized
Item code: 7CN80R
Affected Lot: 202405258X
MHRA reference: 34863736 2025/002/027/601/067
Medtronic: SynchroMed™ A820 myPTM application delays version 2.x
February 2025
Medtronic Reference: FA1460
Implantable Pumps Programmers – MD Software
Model: A820
MHRA reference: 34868107 2025/002/027/601/072
Microbiologics: Helix Elite™ Inactivated Standard HE0044N Inactivated Influenza A/B and Respiratory Syncytial Virus
20 February 2025
FSN Ref: 2025002
Unassayed quality control material for microbiology assays.
Model: HE0044N
Affected serial/LOT range: Refer to FSN
MHRA reference: 34807806 2025/002/021/601/032 – Customer reply form
MHRA reference: 34807806 2025/002/021/601/032 – FSN
Occlutech: Delivery cable Flex-Pusher II (51FP100) in combination with Delivery system ODSIII 6F (98DS006 & 98US006) and ODSv1 6F (51US006)
13.02.2025
FSN identifier: FSN-2025-001
Model: Refer to List of affected products
MHRA reference: 34840838 2025/002/025/601/024
MHRA reference: 34840838 – List of affected products
Smiths Medical: BCI Airway Adapters
27th February 2025
Capnography sampling adaptor
Model: Refer to FSN
MHRA reference: 34828965 2025/002/024/601/015
Werfen/Immucor GTI Diagnostics: PF4 IgG and LIFECODES PF4 Enhanced
21st February 2025
FA #: FA-WKS-25-001
Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)
Model: HAT13G, HAT45G, X-HAT13, X-HAT45
MHRA reference: 34852099 2025/002/026/601/068
Zoll: Powerheart® G5 Semi-Automatic and Automatic AEDs
27 February 2025
Model: G5X-XXX
MHRA reference: 34863909 2025/002/019/601/074