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 - (For webupdates: this is a new link for each week)
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View . FSNs before this date are on the
AD-TECH: Surgical drill guide, reusable
10 September 2019
Surgical power tools
MHRA reference:
Biohit Oyj: BIOHIT ColonView
22 July 2020
IVDs, clinical chemistry
MHRA reference:
Cardinal Health: Protexis Latex Micro Surgical Gloves
29 July 2020
Gloves, surgical & examination
MHRA reference:
Getinge: Datascope Intra-Aortic Ballon Catheters (IABs) 28 July 2020 Cardiac assist pumps MHRA reference:
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:
ITH icoserve technology for healthcare: syngo.share view diagnostic
10 July 2020
Picture archiving and communication system (PACS)
Model: 11250008
MHRA reference:
Philips Healthcare: HeartStart MRx Defibrillator/Monitor
09 July 2020
Defibrillators, non implantable
MHRA reference:
QIAGEN: QIAstat-Dx Respiratory SARS-CoV-2 Panel
16 July 2020
IVDs, SARS-CoV-2 PCR Test
MHRA reference:
Roche Diagnostics: Elecsys CA 19-9
July 2020
IVDs, clinical chemistry
MHRA reference:
Siemens: Cios Spin & Cios Alpha
July 2020
X ray, fluoroscopy systems
MHRA reference:
Siemens Healthcare: syngo.via RT Image Suite, feature synthetic CT
June 2020
Computed tomography
MHRA reference:
Steripack: Syringe NaCl 0,9% Luer Lock 10 ml (5ml fill) *S
31 March 2020
Vascular cannula/catheter accessories
MHRA reference:
Thermo Fisher Scientific: Remel
22 July 2020
IVDs, bacteriology
Model: R30165501
MHRA reference:
Trinity Biotech:Uni-Gold鈩� S. pneumoniae
27 June 2020
IVDs, bacteriology
Model: 1204420
MHRA reference:
WEINMANN Medical Technology: MEDUMAT Standard 2
July 2020
Lung ventilators
Model: 28710
MHRA reference:
LeMaitre Vascular: LeMaitre Over the Wire Embolectomy Catheter
30 July 2020
Vascular cannula and catheters
Model: 1651-84, 1654-88
MHRA reference: