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Field Safety Notices (FSNs) from 8 to 12 January 2024

Medicines Healthcare Products Regulatory Agency

January 16
16:34 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 the 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

Corcym: Perceval Plus Sutureless Aortic Heart Valve

29 December 2023

Model: PVF-S, PVF-M, PVF-L, PVF-XL

MHRA reference: 27801644

GE HealthCare: IC9-RS

Ref. # 79072

Transducer assembly, ultrasound, diagnostic, intra

MHRA reference: 27801249

Medline: Drainage bag

FSN-24/01

MHRA reference: 27811181

Molnlycke: Sternal Refractor 30x19cm 4 blades

10 October 2023

MHRA reference: 27806806

Philips: Intera, Achieva, Ingenia CX

28 December 2023

Magnetic Resonance Imaging (MRI) unit

Model: Achieva 1.5T 781196, 781343, 781296 Achieva 1.5T Conversion 781346, 781283 Achieva 1.5T Initial system 781178 Achieva 3.0T 781277, 781177, 781278, 781344, 781345 Achieva XR 781153, 781253 Ingenia 1.5T CX 781262, 781261 Ingenia 3.0T CX 781271, 782105 Intera 1.5T Achieva Nova 781172 Intera 1.5T Achieva Nova-Dual 781173 Intera Achieva 1.5T Pulsar 781171 SmartPath to dStream for 1.5T 781260, 782112 SmartPath to dStream for XR and 3.0T 781270, 782113, 782129

MHRA reference: 27806801

SERF: Disposable cup impactor(ICJ) - NOVAE STICK 47

20 December 2023

Disposable cup impactor (ICJ)

Model: RM49010002

MHRA reference: 27798737

Stryker: Scorpio, Duracon, PCA, Trident

December 2023 RA2023-3471895

MHRA reference: 27801663

Stryker: HRIS ACET CUP CUT TIP

December 2023

MHRA reference: 27801254

Therapy Equipment: Therapy Flowmeter

21 December 2023

Model: Diamond Range

MHRA reference: 27798734

Zimmer Biomet: Dermacarriers

11 January 2024

Skin graft carrier

Model: 00-2195-013-00

MHRA reference: 27811681

Published 16 January 2024

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