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Field Safety Notice: 11 to 15 November

Medicines Healthcare Products Regulatory Agency

November 18
15:43 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

Published 18 November 2019

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