Field Safety Notices: 24 to 28 February 2025
Source: gov.uk (2025-03-04)

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 the latest FSNs (https://mhra-gov.filecamp.com/s/o/SB0RO13TiBBqWOeE)

View a list of FSNs published since January 2020 (https://mhra-gov.filecamp.com/s/9g5cLjjFatXruS5U/d)

View FSNs since November 2014 (https://mhra-gov.filecamp.com/s/ZOxdOzRzP22RziUW/fo). FSNs before this date are on the National Archives website (https://webarchive.nationalarchives.gov.uk/*/http:/www.mhra.gov.uk/index.htm)

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 (https://mhra-gov.filecamp.com/s/d/W9MrYrpKziYvmf4V) 2025/002/xx-xxxx-xxxx

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 (https://mhra-gov.filecamp.com/s/d/xIoof4nqTtehOXSi) 2025/002/xx-xxxx-xxxx

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 (https://mhra-gov.filecamp.com/s/d/q7mZ7ArsWXXaDlPW) 2025/002/xx-xxxx-xxxx

Medtronic: SynchroMed™ A820 myPTM application delays version 2.x

February 2025

Medtronic Reference: FA1460

Implantable Pumps Programmers – MD Software

Model: A820

MHRA reference: 34868107 (https://mhra-gov.filecamp.com/s/d/B8Cz6XfNmqrhGLvF) 2025/002/xx-xxxx-xxxx

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 (https://mhra-gov.filecamp.com/s/d/ebPTbyCrKpocGSp7) 2025/002/xx-xxxx-xxxx – Customer reply form

MHRA reference: 34807806 (https://mhra-gov.filecamp.com/s/d/czCozilze3DAH5bW) 2025/002/xx-xxxx-xxxx – 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 (https://mhra-gov.filecamp.com/s/d/knSz0WiLZefnjD18) 2025/002/xx-xxxx-xxxx

MHRA reference: 34840838 (https://mhra-gov.filecamp.com/s/d/62FwviwDtLIiKuY5) – List of affected products

Smiths Medical: BCI Airway Adapters

27th February 2025

Capnography sampling adaptor

Model: Refer to FSN

MHRA reference: 34828965 (https://mhra-gov.filecamp.com/s/d/k7h1ZZBHw4but4Ku) 2025/002/xx-xxxx-xxxx

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 (https://mhra-gov.filecamp.com/s/d/ZsouC2h2FgNYphYs) 2025/002/xx-xxxx-xxxx

Zoll: Powerheart® G5 Semi-Automatic and Automatic AEDs

27 February 2025

Model: G5X-XXX

MHRA reference: 34863909 (https://mhra-gov.filecamp.com/s/d/os1udGWkCrL1Txth) 2025/002/019/601/074