Field Safety Notices: 27 September to 01 October 2021

List of field safety notices (FSNs) from medical device manufacturers from 27 September to 01 October 2021

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

Abbott Medical: EnSite X Display Workstation

28 September 2021

Therapy tissue ablation

Model: ENSITE-DWS-01,ENSITE-DWS-1.1,ENSITE-R-DWS-01,ENSITE-R-DWS-1.1,ENSITE-SW-1.0.2, ENSITE-SW-1.1

MHRA reference: 2021/009/028/579/013

Aesculap AG: BIPOLAR CUP TRIAL HEAD

21 September 2021

Orthopaedic surgical instruments - insertion/extraction tools

Model: NF719 NF720 NF721 NF722 NF723 NF724 NF725 NF726 NF727 NF728 NF729 NF730 NF731 NF732 NF733 NF734 NF735 NF743 NF744 NF745 NF746 NF747 NF748 NF749 NF750 NF751 NF752 NF753 NF754 NF755 NF756 NF757 NF758 NF759 NF760 NF762 NF773 NF774 NG080 NG091 NG092 NG093 NG094 NG095 NG096 NG097 NG098 NG099 NG100 NG101 NG102 NG103 NG104 NG105

MHRA reference: 2021/009/027/601/502

Baxter Healthcare: Prismax V2 Roe

14 May 2021

Dialysis, haemofilters

Model: 955558

MHRA reference: 2021/009/028/487/003

Bayer Medical: MEDRAD Twist & Go Disposable Syringe

September 2021

Injection devices

MHRA reference: 2021/009/023/579/007

Chalice Medical: ParaTherm

FSN 20220708

Blood/fluid warming systems

Model: 54-00-16, 54-00-18

MHRA reference: 2021/007/029/601/003

DJO Global: CHATTANOOGA ultrasound gel and lotions

30 August 2021

Ultrasound, imaging

MHRA reference: 2021/009/024/701/068

Elekta: Linear Accelerator

September 2021

Radiotherapy

MHRA reference: 2021/009/028/579/001

Ophtec International: ARTIFLEX phakic IOL, toric phakic IOL

15 September 2021

Intraocular lenses and accessories

Model: 40114SW, 4A0SW, 4C0SW

MHRA reference: 2021/009/022/579/001

Philips Health Systems: EPIQ CVxi

September 2021

Ultrasound, imaging

MHRA reference: 2021/009/028/579/002

Zoll Circulation: COOL LINE, ICY, Quattro and Solex IVTM Catheters

24 September 2021

Vascular cannula and catheters

Model: CL-2259AE, IC-3893-AE, IC-4593AE and SL-2593AE

MHRA reference: 2021/009/028/579/003

Updates to this page

Published 4 October 2021