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
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B Braun: ACTREEN LITE CATH
10 August 2020
Urinary catheters and accessories
Model: 228216E, 228218E, 228212E, 228308E, 228316E
MHRA reference:
Frontier Therapeutics: Repose Lite
20 May 2020
Pressure relief cushions
Model: 6250010, 6251000, 625001, 6251010
MHRA reference:
KARL STORZ: Tubing Set, Irrigation, PC
16 August 2020
Surgical equipment, miscellaneous
MHRA reference:
Thermo Fisher Scientific: TaqPath鈩� 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:
Merge Healthcare: Merge PACS
5 August 2020
Picture archiving and communication system (PACS)
MHRA reference:
Nuvasive: PRECICE Bone Transport Nail
27 July 2020
Osteosynthesis, nails intramedullary
Model: BT10-60SJ280-6
MHRA reference:
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:
Randox Laboratories: Randox Lactate Dehydrogenase L-P and P-L
05 August 2020
IVDs, clinical chemistry
MHRA reference:
Randox: COVID 19 SAMPLE COLLECTION KITS
07 August 2020
IVDs, SARS-CoV-2 PCR Test
Model: EV4429
MHRA reference:
SICAT: SICAT Implant V2.0
15 July 2020
Picture archiving and communication system (PACS)
MHRA reference:
Siemens: Atellica庐 UAS 800 Analyzer, Atellica 庐 1500 Automated Urinalysis System
August 2020
IVDs, clinical chemistry
MHRA reference:
TriMedika: TriTemp TR 1 Non-Contact Infra-Red Thermometer
16 July 2020
Diagnostic measurement and monitoring
MHRA reference:
William Cook Europe: Zenith Alpha庐 Abdominal Endovascular Graft
11 August 2020
Implants, non-active, endoprostheses for aortic aneurysms
MHRA reference: