Field Safety Notices: 19 to 23 September 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from `9 to 23 September 2022.

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

Acumed: 2.7mm x 14mm Locking Hexalobe Screw

15 September 2022

Osteosynthesis, Bone Screws

MHRA reference: 2022/009/016/601/500

Acumed: 2.7mm x 16mm Locking Hexalobe Screw

R22-004

Osteosynthesis, Bone Screws

MHRA reference: 2022/009/016/601/501

Boston Scientific: 41M402, 41M401, 61M401 FARAWAVE - FARASTAR - FARAPULSE SYSTEM Brand

15 September 2022

Therapy Tissue Ablation

MHRA reference: 2022/009/020/611/008

HufriedyGroup: K360 Scalpel Handle

30 August 2022

Surgical Instruments, Non Articulated

MHRA reference: 2022/008/026/596/012

Leica Biosystems: Formula R Paraffin

04 August 2022

IVDs, Cytopathology & Histopathology

MHRA reference: 2022/009/021/596/001

Löwenstein Medical: elisa 600, elisa 800 und elisa 800 vit

02 September 2022

Lung Ventilators

MHRA reference: 2022/009/016/611/006

Nipro Medical Europe: SURDIAL

09 September 2022

Dialysis, Haemodialysis

MHRA reference: 2022/009/015/601/003

Philips: SyncVision System

2021-IGT-IGTD-002

X Ray, Fluoroscopy Systems

MHRA reference: 2022/009/016/601/001

Philips: Amara View Minimal Contact Full-Face Mask (Full Face Mask)

DreamWear Full Face Mask (Full Face Mask)

DreamWisp Nasal Mask with Over the Nose Cushion (Nasal Mask)

Wisp Nasal Mask (Nasal Mask)

Wisp Youth Nasal Mask (Nasal Mask)

Therapy Mask 3100 NC/SP (Nasal Mask)

29 August 2022

Anaesthetic & Breathing, Masks

MHRA reference: 2022/008/015/596/001

The above FSN is comprised of 3 parts:

Roche: cobas 5800 Instrument 08707464001

SBN-RDS-Molecular Lab-2022-005

IVDs, Clinical Chemistry

MHRA reference: 2022/009/013/701/060

Siemens Healthineers: CLINITEK Novus PRO 12 Urinalysis Cassette

September 2022

IVDs, Clinical Chemistry

MHRA reference: 2022/009/015/601/002

ThermoFisher Scientific: CM0301W/B/T/R Thermo Scientific

10 September 2022

IVDs, Bacteriology

MHRA reference: 2022/009/013/601/506

Updates to this page

Published 26 September 2022