Field Safety Notices: 22 to 26 April 2024

List of Field Safety Notices from 22 to 26 April 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 . FSNs before this date are on the

ACE MEDICAL DEVICES: 聽BLADDER EVACUATOR聽

03 April 2024

Bladder evacuator, single-use聽

Model: Universal 聽

MHRA reference: 听听听听

B Braun: ACETABULAR AND HEAD IMPLANTS

22 April 2024

Non-constrained polyethylene acetabular line

Model: NV302E; NV315ENV304E听听

MHRA reference: 听听听听

Baxter: ProBP 3400, Spot Vision Screener and Power Cords

24 April 2024

MHRA reference: FSN听听听听

MHRA reference: 尝别迟迟别谤听听听

Beckman Coulter: DxI 9000 Access Immunoassay Analyzer聽

24 April 2024

Chemiluminescent immunoassay analyzer IVD

Model: C11137

MHRA reference: 听听

Cadwell: Cascade IOMAX Cortical Module

23 April 2024

Neurophysiologic monitoring system聽

MHRA reference: 听听听听

Draeger: Infinity Acute Care System (M540)聽

April 2024

Physiological Monitoring Systems

Model: MS20407听听

MHRA reference: 听听听听

Elekta: Disposable Biopsy Needle Kit聽

April 2024

Stereotactic Surgery System, Neurological聽

Model: 911933 50398-01, 307165, 60377-02, 60377-01, 50376-01, 14001050, 1002248聽

MHRA reference: 听听听听

Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e

23 April 2024

Anesthesia system

MHRA reference: 听听听听聽

HORIBA: ABX Pentra Urea CP

25 March 2024

Urea IVD, reagent

Model: A11A01641 / 1220001641聽

MHRA reference: 听听听听听听

Intersurgical: Various Mapleson F Anaesthetic Breathing Systems聽

24 April 2024

Anaesthesia breathing circuit, single-use

MHRA reference: 听听听听

Intuitive: SureForm45/60, Cannula Seal, Arm Drape, Obturator聽

19 March 2024

Robotic Surgical System聽

Model: 480445-04; 480460-09; 470015-07, 420023-03, 470361-08聽

MHRA reference: 听听听听

Medline: Electrosurgical Electrode

FSN 24-02

MHRA reference: 听听听听

Medtronic: Catheter, Dilation - 30mm

April 2024 FA1413

Gastrointestinal/biliary dilation balloon catheter聽

Model: ES-330听听

MHRA reference: 听听听听

Philips: Igenia with Evolution Upgrade

19 April 2024

Magnetic Resonance Imaging (MRI) unit

Model: 782116, 782117

MHRA reference: 听听听听

Philips: PIC iX, PIC iX Expand聽

2024-CC-HPM-013

Model: 866389, 866390聽

MHRA reference:

Updates to this page

Published 1 May 2024