GovWire

Field Safety Notices: 30 September to 4 October 2024

Medicines Healthcare Products Regulatory Agency

October 4
13:46 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

Siemens Healthineers: ACUSON Juniper and ACUSON Juniper Select Ultrasound systems

08 February 2024

General-purpose ultrasound imaging system

Model: 11335791, 11653093 (System IVK: 11335791)

MHRA reference: 32819130 2024/002/027/601/057

Aidence: Veye Lung Nodules

27 February 2024

Model: 3.22.0

MHRA reference: 28038186

Arjo: IndiGo Intuitive Drive Assistance

14 February 2024

Accessory for basic electric hospital beds

Model: INDI-XXX

MHRA reference: 28028412

Baxter: Flo-Rester, Flo-Thru, Vascular Probe, Ma Recette

29 February 2024

Surgical intravascular shunt

MHRA reference: 28043281 Letter

MHRA reference: 28043281 FSN

BD: BodyGuard MicroSet

26 February 2024

Electric infusion pump admin set,single use

MHRA reference: 28028023

Beckman Coulter: DxA Automation System / DxA Aliquoter

23 February 2024 FSN-24006

Specimen processing instrument IVD, automated

MHRA reference: 28043275

Beckman Coulter: Access Substrate

23 February 2024

Chemiluminescent substrate reagent IVD

Model: 81906

MHRA reference: 28043269

bioMrieux: BIOFIRE Pneumoniaplus (PNplus) Panel

08 February 2024

Multiple-type respiratory pathogen nucleic acid

Model: RFIT-ASY-0142 (PNplus, 30-pack), RFIT-ASY-0143 (PNplus, 6-pack)

MHRA reference: 27943715

bioMrieux: MUELLER HINTON E AGAR

26 Jan 2023

Mueller-Hinton agar antimicrobial susceptibility

MHRA reference: 27942675

BVI: 581012 - IRRIGATION HANDLE (20/SP)

13 February 2024

MHRA reference: 28029327

CONMED: HIP PRESERVATION SYSTEM SIGNATURE SERIES

09 February 2024

Arthroscopic shaver system blade, single-use

MHRA reference: 28043125

Cook: Dilators - Coons Taper, EntuitSecure Adjustable Gastrointestinal Suture Anchor Sets, Chiba Biopsy Needles

28 February 2024

Model: JCD22.0-38-20-COONS, GIAS-SRM-ADJ-2, DCHN-22-15.0, DCHN-22-15.0-U

MHRA reference: 28028797

27 February 2024

Model: 17-5220/01

MHRA reference: 28040570

Luminex: NxTAG Respiratory Pathogen Panel

25 January 2024

MHRA reference: 28038177 Letter

MHRA reference: 28038177 FSN

Medicina: ENFit double-lumen polyurethane Replogle tube

12 February 2024

Model: NF02L

MHRA reference: 28030507

Olympus: SOLTIVE SuperPulsed Laser System

28 February 2024

General/multiple surgical solid-state laser system

Model: TFL-PLS, TFL-SLS

MHRA reference: 28029779

Randox: MICROALBUMIN CALIBRATOR SERIES (mALB CAL)

31 January 2024

Microalbumin IVD, calibrator

MHRA reference: 28028402

RaySearch Laboratories: RayStation

23 February 2024

Model: 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A

MHRA reference: 28043273

Roche: t 511/ t 711: PT-aPTT

April 2023

MHRA reference: 27919638

Siemens Healthineers: ACUSON Redwood ultrasound system

Ref: US005-24-S + US011-12-24-S

General-purpose ultrasound imaging system

Model: 11503314

MHRA reference: 28037799

Updates to this page

Published 4 October 2024

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