Field Safety Notices: 28 March to 1 April 2022
List of field safety notices (FSNs) from medical device manufacturers from 28 March to 1 April 2022.
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
The 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: TactiCath Contact Force Ablation Catheter, SE
24 March 2022
Therapy tissue ablation
Model: A-TCSE- DF; A-TCSE- DD
MHRA reference: 2022/003/029/291/001
Abbott: Alinity i Homocysteine Reagent Kit
24MAR2022
IVDs, clinical chemistry
MHRA reference: 2022/003/025/701/070
Baxter: Artiset HD DNL HC
23 March 2022
Dialysis, blood lines
MHRA reference: 2022/003/024/291/003
ConvaTec: Suction Catheters
TW1527576
Airway suction equipment
MHRA reference: 2022/003/029/291/002
Corin: MetaFix 579.1007
22 March 2022
Joint prosthesis, hip
MHRA reference: 2022/003/025/601/007
Getinge: Advanta V12 Covered Stent System
02 March 2022
Implants, non active, peripheral vascular stents
MHRA reference: 2022/003/011/291/002
Getinge: GETINGE CM320-SERIES
21 March 2022
Cssd wash/clean/drying equipment
Model: CM320-2 Chamber WD, CM320-2 Chamber WU, CM320-4
MHRA reference: 2022/003/024/291/005
Intuitive: SureForm 45, 45 Curved-Tip, 60
ISIFA2022-02-C
Staples and staple guns
Model: 480445, 480545, 480460
MHRA reference: 2022/003/030/701/034
Medtronic: Puritan Bennett 980 Ventilator System
March 2022
Lung ventilators
Model: ALL
MHRA reference: 2022/003/029/291/003
Philips: StentBoost Live used with Philips Azurion
02 February 2022
X Ray, fluoroscopy systems
Model: StentBoost Live: 459801781661 Phillips Azurion: 722079, 722136, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228
MHRA reference: 2022/002/007/487/010
Randox: Total Bile Acids
18 February 2022
IVDs, clinical chemistry
MHRA reference: 2022/003/004/601/501
Seegene: Allplex SARS-CoV-2 Variants II Assay
FSN-20220225-RV10305X
IVDs, SARS-CoV-2 PCR Test
Model: RV10305X, RV10306Y
MHRA reference: 2022/003/018/601/003
Sentinel Diagnostics: Copper, Clin Chem Control 1 & 2
23 March 2022
IVDs, clinical chemistry
MHRA reference: 2022/003/024/291/007
Siemens Medical Solutions: Symbia Intevo 6 and Intevo Bold
CAN 022-2022
SPECT-CT
Model: 10764803, 11007962
MHRA reference: 2022/003/016/601/500