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 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