Field Safety Notices: 6 to 10 December 2021
List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 December 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 FSNs since November 2014.
FSNs before this date are on the National Archives website
Convatec: Avelle Negative Pressure Wound Therapy Pump
25 November 2021
Active wound management
MHRA reference: 2021/011/015/291/015
Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
23 November 2021
Anaesthetic machines & monitors
Model: Isoflurane 6682280 & 6886621, Desflurane 6682287 & 6886631, Sevoflurane 6682285, 6886611, 6682282 & 6887135.
MHRA reference: 2021/012/006/487/003
Invacare: AVIVA RX
30 November 2021
Wheelchairs, powered
MHRA reference: 2021/011/030/701/055
Medline International: Soft suction liner
03 December 2021
Surgical equipment, miscellaneous
MHRA reference: 2021/012/008/487/004
Medtronic: HawkOne Directional Atherectomy System
December 2021/ FA1203
Vascular cannula/catheter accessories
MHRA reference: 2021/012/008/487/007
Medtronic: LigaSure Blunt Tip Laparoscopic Sealer/Divider
December 2021/ FA1215
Surgical, diathermy
Model: Nano-coated LF1837
MHRA reference: 2021/012/008/487/005
Philips Medical: Philips Azurion biplanes, monoplanes with a floor mounted configuration and PolyG2 monoplanes with Software R2.2
November 2021
X Ray, fluoroscopy systems
Model: 722221, 722228, 722225, 722068, 722226, 722078, 722224
MHRA reference: 2021/012/006/487/002
Philips: Zenition 50, Zenition 70 & Veradius Unity
December 2021
X Ray, fluoroscopy systems
Model: Wireless Foot switch 3P: 459801238191
Wireless Foot switch 3P: 459801238231
MHRA reference: 2021/012/008/487/006
QIAGEN: QIAcube Connect MDx
18 November 2021
IVD, genetic testing
MHRA reference: 2021/012/006/487/004
Randox Health: Drugs of Abuse Array
2 November 2021
IVDs, blood transfusion
MHRA reference: 2021/011/023/601/502
Schiller Medical: DEFIGARD Touch-7 (Update to FSN 10 to 14 Feb 2021)
November 2021
Defibrillators, non implantable
MHRA reference: 2021/012/008/487/003
Siemens Healthcare: Atellica CH 930 Analyzer
November 2021
IVDs, clinical chemistry
Model: SMN 11067000
MHRA reference: 2021/011/026/601/002