Field Safety Notices: 7 to 11 October 2024

List of Field Safety Notices (FSNs) from 7 to 11 October 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

Bactiguard : ZNN™ BACTIGUARD® Bactiguard Implants

26th August 2024

Bone Nail End-Cap

MHRA reference: 31837311     2024/007/031/601/034 

Croma: NuVisc Pro

12th September 2024

Model: 37284, 37758

MHRA reference: 32836459   2024/009/006/601/032

Freenome Ltd: EarlyCDT Lung Cancer Test Kit

03 October 2024

Batch Number: ECDTL2-KIT-006 and ECDTL2-KIT-007

Software version: 3.0.2

MHRA reference: 32836536   2024/010/003/601/046

GE Healthcare: Ultrasound system type 2300

FMI 87012

Ultrasound system, Imaging, General purpose

Model: 2300-11(bk3000) and 2300-61(bk5000), 2300-66(bkActiv)

MHRA reference: 32891269     2024/009/023/601/041  

Jenx: Ly-on

19th September 2024

MHRA reference: 32821621    2024/009/019/601/023 

Merivaara : Merivaara Q-Flow surgical lights

02 October 2024

Operating room light system

Model: Q-FLOW SOLO, Q-FLOW DUO, Q-FLOW TRIO, Q-FLOW QUAD,Q-FLOW MOBILE

MHRA reference: 32893660    2024/010/003/601/044  

Olympus : OFP 2 Flushing Pump

20th September 2024

Surgical Irrigation Pump

MHRA reference: 32836730    2024/009/017/601/088 

Olympus: Outer sheath, 22.5 Fr.

11th October 2024

Cystoscopes, Rigid

Model: WA22810A

MHRA reference: 32877518     2024/010/009/601/037

Philips: Trilogy Evo ,Trilogy Evo O2, Trilogy EV300

9th July 2024

Portable Electric Ventilator

Model: Please refer to Units Affected List

MHRA reference: 32879230     2024/010/010/601/024

SINOVO health solutions GmbH: mylife App

Mylife Diabetes care

GENERAL MEDICINE DIAGNOSIS& MONITORING INSTRUMENTS

Software version: All app versions from v2.1.1 upwards

MHRA reference: 32846979   2024/010/007/601/017

Smith & Nephew, Inc: LEGION OXINIUM Constrained Femorals

02 October 2024

Batch number: 23LM00479 and 23LM03388

MHRA reference: 32843226   2024/010/007/601/082

Smiths Medical: ParaPAC plus™ Model 300 and Model 310 Ventilator

10 October 2024

Portable pneumatic ventilator

Model: 300 and 310

MHRA reference: 32842993   2024/010/007/601/045

MHRA reference: 32842993   - Response form

Stryker: ASSEMBLY, INTERNAL PADDLES, LP15, 3.0

September 2024

Model: Refer to FSN

MHRA reference: 32837892   2024/010/003/601/023

Updates to this page

Published 16 October 2024