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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 . FSNs before this date are on the

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: 聽聽 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: 聽聽 2025/002/021/601/031

Medtronic: Shiley鈩� Adult Flexible Tracheostomy Tube with TaperGuard鈩� Cuff Reusable Inner Cannula

27th February 2025

Medtronic Reference: FA1480

Tracheostomy tube, non-reinforced, non-customized

Item code: 7CN80R

Affected Lot: 202405258X

MHRA reference: 聽聽 2025/002/027/601/067

Medtronic: SynchroMed鈩� A820 myPTM application delays version 2.x

February 2025

Medtronic Reference: FA1460

Implantable Pumps Programmers 鈥� MD Software

Model: A820

MHRA reference: 聽聽 2025/002/027/601/072

Microbiologics: Helix Elite鈩� 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: 聽聽 2025/002/021/601/032 鈥� Customer reply form

MHRA reference: 聽聽 2025/002/021/601/032 鈥� 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: 聽聽 2025/002/025/601/024

MHRA reference: 聽聽 鈥� List of affected products

Smiths Medical: BCI Airway Adapters

27th February 2025

Capnography sampling adaptor

Model: Refer to FSN

MHRA reference: 聽聽 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: 聽聽 2025/002/026/601/068

Zoll: Powerheart庐 G5 Semi-Automatic and Automatic AEDs

27 February 2025

Model: G5X-XXX

MHRA reference: 聽聽 2025/002/019/601/074