Field Safety Notices: 4 to 8 December 2023
Field Safety Notices from 4 to 8 December 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 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 Ø15mm, Radius PE Cup Ø15 mm Large, and Radius PE Cup Ø15 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