Field Safety Notices - 31 July - 07 August 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 31 July to 07 August 2020.
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
CareFusion (BD): BD Alaris™ System Infusion Pump
3 August 2020
Infusion systems
MHRA reference: 2020/008/003/291/004
Handicare AB: SwiftHook
20 December 2019
Hoists and slings
Model: 70200008
MHRA reference: 2019/012/024/487/001
LivaNova: Dual collapser – size S/M
29 July 2020
Implants, non active, cardiovascular heart valves
MHRA reference: 2020/007/027/291/001
Luminex Corporation: Amplification Well Temperature Verification Fixture (FA-0005-01), Elution Well Temperature Verification Fixture (FA-0006-01), Sample Well Temperature Verification Fixture (FA-0007-01), Hybridization Cartridge Temperature Verification Fixture (FA-0008-01), Z-Axis Calibration Gauge (FA-0013-01), VERIGENE® Reader Alignment Slide (FA-0014-01)
24 July 2020
IVDs, bacteriology
MHRA reference: 2020/008/004/291/003
Maquet Cardiopulmonary (GETINGE): Product name listed in Annex 1 and comment section
31 July 2020
Heart lung machines
Model: 701072163, 701072162, 701046405, 701043290, 701043291, 701043292, 701043296, 701043299, 701051696, 701051697, 701054401
MHRA reference: 2020/008/005/487/004
Randox Laboratories: Randox Ammonia
30 July 2020
IVDs, clinical chemistry
MHRA reference: 2020/007/030/601/007
Roche Diagnostics: Elecsys Anti-TPO
July 2020
IVDs, Immunology
MHRA reference: 2020/007/031/291/005
Rocket Medical: FBS Fetal Blood Sampling Kit
INT COMP-127
Storage & collection devices
MHRA reference: 2020/007/027/601/002
Siemens Healthcare: Artis zee & Artis Q
July 2020
X ray, fluoroscopy systems
MHRA reference: 2020/008/003/601/008
Siemens Healthcare GmbH: Sola, Vida; 11291455, 11060815
June 2020
Magnetic resonance, equipment & accessories
MHRA reference: 2020/008/003/291/007
Smith & Nephew Inc: GENESIS II Tibial Base Plate
22 July 2020
Joint prosthesis, knee
MHRA reference: 2020/007/031/291/001
Smith and Nephew Inc (Endoscopy): SUTUREFIX ULTRA 1.7MM DRILL (S)
24 June 2020
Surgical power tools
MHRA reference: 2020/007/031/291/004
Smith & Nephew: T-FIX RCG Sterile Drill
24 June 2020
Surgical power tools
MHRA reference: 2020/007/031/291/003
Smith & Nephew Orthopaedics AG: POLARSTEM COLLAR Reamer Guide
22 July 2020
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: 2020/007/031/291/002
Welch Allyn: Various Welch Allyn Patient Cables and Lead Sets
30 July 2020
ECG
Model: 9293-046-XX, 9293-047-XX, 9293-017-XX, 9293-026-XX 9293-061-XX, 9293-033-XX, 9293-034-XX, (X can be any combination of 0-9)
MHRA reference: 2020/003/019/487/001
Williams Medical Supplies: Paxxon Disposable Forceps
19 June 2020
Surgical instruments, articulated holding
Model: D2601
MHRA reference: 2020/007/016/601/004