Field Safety Notices - 2 January - 6 January 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 2 - 6 January 2017

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

Acutronic Medical Systems

01 November 2016

Lung ventilators

Model: Fabian HFO

MHRA reference: 2016/011/015/291/011

Advanced Fiber Tools: Radial Fiber

3 January 2017

Therapy, lasers

Model: VARI-Co 360° fiber

MHRA reference: 2016/012/016/299/019

Beckman Coulter: UniCel DxH 800/600 Cellular Analysis Systems

2 December 2016

IVDs, haematology

MHRA reference: 2017/001/003/601/005

Boston Scientific: Imager™ II Angiographic Catheter

19 December 2016

Vascular cannula and catheters

Model: Recall: M001314141 Advisory: Refer to appendix A

MHRA reference: 2016/012/020/291/021

Corin: Trinity acetabular shell

18 November 2016

Joint prosthesis, hip

Model: 321.03.352

MHRA reference: 2016/011/018/601/003

Depuy Synthes: Synthes Radial Head Prosthesis

30 December 2016

Joint prosthesis, elbow

MHRA reference: 2017/001/005/299/001

Maquet: Cardiosave Hybrid/Rescue IABP Li-Ion Battery

23 December 2016

Cardiac assist pumps

Model: IABP 0998-xx-0800-xx; Battery 0146-00-0097

MHRA reference: 2016/012/029/291/010

Ortho Clinical: VITROS® Chemistry Products Na+ Slides

3 January 2016

IVDs, clinical chemistry

MHRA reference: 2017/001/002/601/001

Siemens: syngo RT Oncologist

TH006/16/S

Radiotherapy

MHRA reference: 2017/001/005/601/001

Siemens: VERSANT kPCR Molecular System Sample Preparation

4 January 2017

IVDs, viral microbiology

MHRA reference: 2017/001/004/601/009

Stryker: TLS and SPG Drain System, Medpor Facial implants

January 2017

Wound drains

Model: see attached list

MHRA reference: 2016/012/028/701/010

Zimmer Biomet: Comprehensive Reverse Shoulder Tray

20 December 2106

Joint prosthesis, shoulder

MHRA reference : 2016/012/030/701/004

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