Field Safety Notices: 10 - 14 August 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 10 August to 14 August 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
View a list of FSNs published since January 2020
View FSNs since November 2014 FSNs before this date are on the National Archives website
B Braun: ACTREEN LITE CATH
10 August 2020
Urinary catheters and accessories
Model: 228216E, 228218E, 228212E, 228308E, 228316E
MHRA reference: 2020/008/011/601/001
Frontier Therapeutics: Repose Lite
20 May 2020
Pressure relief cushions
Model: 6250010, 6251000, 625001, 6251010
MHRA reference: 2020/008/006/601/010
KARL STORZ: Tubing Set, Irrigation, PC
16 August 2020
Surgical equipment, miscellaneous
MHRA reference: 2020/008/006/487/004
Thermo Fisher Scientific: TaqPath™ COVID-19 CE-IVD Interpretive Software
05 August 2020
IVDs, SARS-CoV-2 PCR test
Model: 100093771; v1.2, 100094143: v2.1; 100094318; v2.2
MHRA reference: 2020/007/020/291/003
Merge Healthcare: Merge PACS
5 August 2020
Picture archiving and communication system (PACS)
MHRA reference: 2020/008/006/701/003
Nuvasive: PRECICE Bone Transport Nail
27 July 2020
Osteosynthesis, nails intramedullary
Model: BT10-60SJ280-6
MHRA reference: 2020/007/029/601/001
Philips Healthcare: OmniDiagnost Eleva
MultiDiagnost Eleva with Flat Detector
Integris CV
Allura Xper FD10 Ceiling
Allura Xper FD10 Floor
Allura Xper FD10
Allura Xper FD10/10
Allura Xper FD20
Allura Xper FD20 Biplane
Allura Xper FD10
Allura Xper FD10/10
Allura Xper FD20
Allura Xper FD20 Biplane
Allura Xper FD10 OR Table
Allura Xper FD20 OR Table
Allura Xper FD20 Biplane OR Table
Allura Xper FD20 OR Table
Allura Xper FD10
Allura Xper FD10/10
Allura Xper FD20
Allura Xper FD20/10
Allura CV20
Allura Xper FD20 OR Table
Allura Xper FD20/20
Allura Xper FD20/20 OR Table
Allura Xper FD20/15
Allura Centron
28 July 2020
X ray, general
Model: 708027, 708032, 708034, 708036, 708037, 708038, 722001, 722003, 722005, 722006, 722008,722010, 722011, 722012, 722013, 722014, 722015, 722020, 722023, 722026, 722027, 722028, 722029, 722030, 722031, 722035, 722038, 722039, 722058 and 722400
MHRA reference: 2020/008/010/487/008
Randox Laboratories: Randox Lactate Dehydrogenase L-P and P-L
05 August 2020
IVDs, clinical chemistry
MHRA reference: 2020/008/007/487/001
Randox: COVID 19 SAMPLE COLLECTION KITS
07 August 2020
IVDs, SARS-CoV-2 PCR Test
Model: EV4429
MHRA reference: 2020/008/010/601/004
SICAT: SICAT Implant V2.0
15 July 2020
Picture archiving and communication system (PACS)
MHRA reference: 2020/008/011/291/007
Siemens: Atellica® UAS 800 Analyzer, Atellica ® 1500 Automated Urinalysis System
August 2020
IVDs, clinical chemistry
MHRA reference: 2020/008/011/601/005
TriMedika: TriTemp TR 1 Non-Contact Infra-Red Thermometer
16 July 2020
Diagnostic measurement and monitoring
MHRA reference: 2020/007/021/291/004
William Cook Europe: Zenith Alpha® Abdominal Endovascular Graft
11 August 2020
Implants, non-active, endoprostheses for aortic aneurysms
MHRA reference: 2020/008/010/487/007