Field Safety Notices - 27 July - 31 July 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 27 July to 31 July 2020
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 - (For webupdates: this is a new link for each week)
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
AD-TECH: Surgical drill guide, reusable
10 September 2019
Surgical power tools
MHRA reference: 2020/005/016/601/002
Biohit Oyj: BIOHIT ColonView
22 July 2020
IVDs, clinical chemistry
MHRA reference: 2020/007/029/487/003
Cardinal Health: Protexis Latex Micro Surgical Gloves
29 July 2020
Gloves, surgical & examination
MHRA reference: 2020/007/028/701/046
Getinge: Datascope Intra-Aortic Ballon Catheters (IABs) 28 July 2020 Cardiac assist pumps MHRA reference: 2021/001/008/701/013
Globus Medical: ALTERA
22 July 2020
Spinal implants
Model: 1124.1011, 1124.1012, 1124.1013, 1124.1015, 1124.1032, 1124.1033, 1124.1035, 1124.1111, 1124.1112, 1124.1113, 1124.1115, 1124.1132, 1124.1133, 1124.1135, 1124.1211, 1124.1212, 1124.1213, 1124.1215, 1124.1232, 1124.1233, 1124.1235, 1124.1111S
MHRA reference: 2020/007/030/701/007
ITH icoserve technology for healthcare: syngo.share view diagnostic
10 July 2020
Picture archiving and communication system (PACS)
Model: 11250008
MHRA reference: 2020/007/029/601/004
Philips Healthcare: HeartStart MRx Defibrillator/Monitor
09 July 2020
Defibrillators, non implantable
MHRA reference: 2020/007/029/487/008
QIAGEN: QIAstat-Dx Respiratory SARS-CoV-2 Panel
16 July 2020
IVDs, SARS-CoV-2 PCR Test
MHRA reference: 2020/007/028/291/002
Roche Diagnostics: Elecsys CA 19-9
July 2020
IVDs, clinical chemistry
MHRA reference: 2020/007/028/291/001
Siemens: Cios Spin & Cios Alpha
July 2020
X ray, fluoroscopy systems
MHRA reference: 2020/007/028/601/002
Siemens Healthcare: syngo.via RT Image Suite, feature synthetic CT
June 2020
Computed tomography
MHRA reference: 2020/007/024/601/005
Steripack: Syringe NaCl 0,9% Luer Lock 10 ml (5ml fill) *S
31 March 2020
Vascular cannula/catheter accessories
MHRA reference: 2020/002/013/291/004
Thermo Fisher Scientific: Remel
22 July 2020
IVDs, bacteriology
Model: R30165501
MHRA reference: 2020/007/023/601/006
Trinity Biotech:Uni-Gold™ S. pneumoniae
27 June 2020
IVDs, bacteriology
Model: 1204420
MHRA reference: 2020/006/030/291/009
WEINMANN Medical Technology: MEDUMAT Standard 2
July 2020
Lung ventilators
Model: 28710
MHRA reference: 2020/007/029/487/004
LeMaitre Vascular: LeMaitre Over the Wire Embolectomy Catheter
30 July 2020
Vascular cannula and catheters
Model: 1651-84, 1654-88
MHRA reference: 2020/003/025/487/009