GovWire

Field Safety Notices: 4 to 8 December 2023

Medicines Healthcare Products Regulatory Agency

December 12
17:30 2023

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

Abbott: Proclaim, Infinity

December 2023

Spinal Cord-, Deep Brain electr. stimulation sys.

Model: 3660, 3662, 3664, 6660, 6662

MHRA reference: 27668080

Amity: Virusolve+ Concentrate / Virsuolve+ RTU

4 December 2023

Medical device disinfection agent

MHRA reference: 27653390

BD: BodyGuard Infusion Pumps Systems (LVP)

29 November 2023

MHRA reference: 27662814

Integra: CODMAN VPV SYSTEM

1 December 2023

Cerebrospinal fluid shunt valve programmer

MHRA reference: 27653396

KARL STORZ: BEYER Antrum Punch

615010 Antrum Punch, 65, 11 cm

615025 Sphenoid Punch, 30, 11 cm

648500 Sphenoid Punch, 3.2 x 4 mm

648523 Sphenoid Punch, 30, 1.6 x 2 mm

662797 Galea Spring Hook, 31 cm

723014 Uvula Retractor

723400 Optical Biopsy and Grasping Forceps

11003MB Grasping Forceps, flexible, 1 mm

26161UH Working Insert, with steering lever

11540OS Optical Scissor

1 December 2023

MHRA reference: 27655267

Medtronic: Percutaneous Pin Cross-Pin

7 December 2023

Orthopaedic stereotactic surgery system

Model: 9733235: 2023010549, 2023010551, 2023010840, 2023041134, 2023051137, 2023051138, 2023051139, 2023060368, 2023060369. Model 9733236: 2022030438, 2023041136, 2023041141, 2023041143, 2023051122, 2023051457

MHRA reference: 27664059

Medtronic: NIM Trivantage EMG Endotracheal tube

November 2023 FA1369

Basic endotracheal tube, single-use

Model: 8229706, 8229707, 8229708, 8229736, 8229737, 8229738

MHRA reference: 27663829

Philips: CareEvent

28 November 2023

Model: 866435/866436

MHRA reference: 27652104

Philips: Azurion, Allura

31 October 2023

Interventional Fluoroscopic X-Ray System

Model: 72246, 722001, 722003, 722006, 722010, 722012, 722015, 722016, 722018, 722022, 722023, 722026, 722028, 722033, 722035, 722043, 722078, 722079, 722223, 722224, 722227, 722228

MHRA reference: 27663833

Siemens Healthineers: MAGNETOM

August 2023

MRI system, full body

MHRA reference: 27663855

Siemens Healthineers: Luminos Fusion VD FD, LUMINOS Impulse

XP044/23/S

MHRA reference: 27663861

Swemac: Motec Wrist Joint Prosthesis System

23 November 2023

Model: Radius PE-cup 15mm, Radius PE Cup 15 mm Large, and Radius PE Cup 15 mm Revision

MHRA reference: 27665675

The Insides Company: The Insides System

30 November 2023

Model: PS005

MHRA reference: 27651688

VOSTRA: Rhinotamp

30 November 2023

Nasal haemostatic balloon

Model: RHINOTAMP 70 x 17 x 10 mm

MHRA reference: 27656535

Published 12 December 2023

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