Field Safety Notices: 25 to 29 April 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 April 2022
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website.
Abbott: Dragonfly Opstar Imaging Catheter
11 April 2022
Optical coherence tomography
Model: 1014651, 1014652
MHRA reference: 2022/004/009/701/007
Avanos Medical: CORTRAK 2 Enteral Access System
25 March 2022
Feeding systems and tubes
MHRA reference: 2022/004/011/601/505
Baxter Healthcare: EASYGRIP FLO-41 Precision MIS Delivery System
11 April 2022
Haemostatic agents
MHRA reference: 2022/004/019/291/003
Osatu, S Coop: REANIBEX300, REANIBEX500/BEXEN CARDIO/OSATU S.COOP
04 April 2022
Defibrillators, non implantable
MHRA reference: 2022/004/021/291/003
EBR Systems: WiSE CRT System
14 April 2022
Implants, active, intracardiac (leadless)
Model: WiSE CRT System
MHRA reference: 2022/004/014/701/095
EBR Systems: WiSE CRT Programmer
FSN 22-004
Implants, active, intracardiac (leadless)
Model: 5100
MHRA reference: 2022/004/015/701/004
Endo Tools Therapeutics: 1. TAPES; 2. endomina v2
21 March 2022
Sutures
MHRA reference: 2022/004/004/601/502
Medtronic: Cobalt XT, Cobalt, Crome Implantable Cardioverter/Defibrillator Systems
April 2022
Implants, active, cardiac resynchronisation therapy
Model: Cobalt XT VR: DVPA2D1, DVPA2D4 Cobalt VR: DVPB3D1, DVPB3D4 Cobalt XT DR: DDPA2D1, DDPA2D4 Cobalt DR: DDPB3D1, DDPB3D4 Cobalt XT HF: DTPA2D4, DTPA2D1 Cobalt HF: DTPB2D4, DTPB2D1 Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1 Cobalt HF Quad: DTPB2QQ, DTPB2Q1 Crome VR: DVPC3D1, DVPC3D4 Crome DR: DDPC3D1, DDPC3D4 Crome HF: DTPC2D4, DTPC2D1 Crome HF Quad: DTPC2QQ, DTPC2Q1
MHRA reference: 2022/004/021/291/002
Ortho Clinical Diagnostics: ORTHO Optix Reader ORTHO BioVue Cassettes
19 April 2022
IVDs, Blood Transfusion
Model: 6842223
MHRA reference: 2022/004/013/601/507
Philips: V60 Ventilator V60 PLUS, V680
21 April 2022
Lung ventilators
MHRA reference: 2022/003/021/291/006
Phoenix: Volumed set
26 April 2022
MHRA reference: 5331276
Radiometer: PICO50 Arterial Blood Sampler
FRM-02872
Storage & collection devices
MHRA reference: 2022/004/019/291/004
Randox: CK-MB Calibrator
25 March 2022
IVDs, clinical chemistry
MHRA reference: 2022/004/011/601/501
Siemens: ARTIS icono
April 2022
X Ray, fluoroscopy systems
MHRA reference: 2022/004/011/601/502
ThermoFisher: Phadia 200
FSN2022-02
IVDs, immunology
Model: 12-4300-00
MHRA reference: 2022/004/005/601/504
Water: Xevo TQ-S, TQD, TQ-S Micro and TQ-XS
1218959-10.08.2021-001-C
IVDs, clinical chemistry
Model: 186005453IVD, 186005833IVD, 186007833IVD, 186008453IVD
MHRA reference: 2022/004/013/601/506