GovWire

Field Safety Notices: 23 to 27 October 2023

Medicines Healthcare Products Regulatory Agency

October 31
16:24 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

Arjo: IndiGo Intuitive Drive Assistance

11 September 2023

Accessory for basic electric hospital beds

Model: INDI-XXX

MHRA reference: 27495161

B Braun: Original Perfusor Line

30 August 2023

Intravenous administration tubing extension set

MHRA reference: 27502591

Balt Extrusion: HYBRID / SONIC

11 October 2023

Hydrophilic guidewire (HYBRID) / Selective and Hyperselective catheter (SONIC)

Model: HYBRID1214D 00506800
HYBRID007D 00506369
HYBRID008D 00521942
HYBRID008J 00520501
HYBRID1214DA 00514715
HYBRID007J 00520500
HYBRID1214D 00506801
SONIC1.2F15/HYBRID007D-KIT 00524096
SONIC1.2F25/HYBRID007D-KIT 00513093
SONIC1.2F15/HYBRID007D-KIT 00513550

MHRA reference: 27459274

Carestream: DRX-REVOLUTION MOBILE X-RAY SYSTEM

27 September 2023

X-Ray system, general-purpose, mobile, digital

MHRA reference: 27484810

Elekta: Linear Accelerator

October 2023

Accelerator system, linear

MHRA reference: 27502632

Illumina: NextSeq 550Dx Instrument / MiSeq Dx Instrument

25 October 2023

Nucleic acid sequence analyser IVD, NGS

MHRA reference: 27495204

Philips: Brilliance CT Big Bore; Philips CT Big Bore

9 October 2023

Full-body CT system

Model: 728242, 728243, 728244

MHRA reference: 27492800

Published 31 October 2023

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