Field Safety Notice: 11 to 15 November
List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 November 2019.
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
Beckman Coulter: iChemVELOCITY and iQ200
04 November 2019
IVDs, clinical chemistry
MHRA reference: 2019/011/008/601/006
Beckman Coulter: iChem VELOCITY Urine Chemistry Analyzer
05 November 2019
IVDs, clinical chemistry
MHRA reference: 2019/011/013/601/002
BIOMERIEUX: Cetrimide Agar
FSCA 4553
IVDs, bacteriology
Model: Lot. #1007530990
MHRA reference: 2019/010/029/291/009
CapsoVision: CapsoCam Plus (SV-3)
06 November 2019
Endoscopes, televisual systems
MHRA reference: 2019/011/013/291/009
Cook Medical: Torcon NB® Advantage Catheter
22 October 2019
Vascular cannula and catheters
Model: Torcon NB® Advantage Catheter
MHRA reference: 2019/011/005/291/001
Cordis: PRECISE, S.M.A.R.T., S.M.A.R.T. Control
13 November 2019
Implants, non active, peripheral vascular stents
MHRA reference: 2019/011/014/291/002
Depuy Synthes: USS II Polyaxial
13 November 2019
Spinal implants
Model: 04.607.402, 04.607.402S
MHRA reference: 2019/011/013/291/013
Diagnostica Stago: Devices listed in appendix
November 2019
Coagulation
MHRA reference: 2019/011/013/291/014
GCE: Airway suction equipment
24 September 2019
Airway suction equipment
Model: MediEject II, 07354xx
MHRA reference: 2019/011/011/601/001
Imtmedical AG: bellavista 1000 XX, bellavista 950
30 October 2019
Lung ventilators
MHRA reference: 2019/011/008/701/002
Maquet: ROTAFLOW Drive unit, blue
14 November 2019
Heart lung machines
Model: 70102.2161; 70101.0875; 70105.1427, MCP0.0952291
MHRA reference: 2019/011/014/291/006
Medacta International: Humeral Anatomical Metaphysis
04 November 2019
Joint prosthesis, shoulder
MHRA reference: 2019/011/008/701/014
Medisoft: Medisoft Ophthalmology
06 November 2019
Optical, ophthalmic instruments & equipment
MHRA reference: 2019/011/010/291/018
Medtronic
November 2019
Implants, active, defibrillators
Model: Evera, Visia AF ICDs and Viva, Brava, Claria, Amplia, Compia CRT
MHRA reference: 2019/005/001/420/001
TomTec Imaging Systems: TOMTEC-ARENA
19 September 2019
Ultrasound, imaging
Model: TTA2
MHRA reference: 2019/010/023/291/004
TORNIER SAS: Aequalis Ascend Flex Shoulder System
12 November 2019
Joint prosthesis, shoulder
Model: Aequalis Ascend Flex Shoulder System
MHRA reference: 2019/011/007/487/021