Field Safety Notice - 04 to 08 September 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 September 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 FS Ns

Abbott: Alinity hq Analyzer

31 August 2017

IVDs, haematology

Model: Alinity hq Analyzer

MHRA reference: 2017/009/004/291/001

Applied Medical: Kii® Optical Z-Thread Dual Packs

04 September 2017

Surgical instruments, minimal access

Model: CTR14

MHRA reference: 2017/009/005/291/001

Beckman Coulter: AQUIOS CL Flow Cytometer System

31 August 2017

IVDs, haematology

MHRA reference: 2017/009/001/601/014

Biomet

31 August 2017

Osteosynthesis, nails intramedullary

Model: Affixus hip fracture nail

MHRA reference: 2017/009/006/701/010

Braun and Company: SCT Range Braun Tourniquet

31 August 2017

Surgical equipment, tourniquets

Model: SCT Range Braun Tourniquet

MHRA reference: 2017/009/001/601/007

Depuy Synthes: 8cm Angled Attachment

31 August 2017

Surgical power tools

Model: QD8

MHRA reference: 2017/009/004/291/002

Eschmann

07 September 2017

Operating table

Model: T20 & T30

MHRA reference: 2015/011/003/401/002

Ethicon

September 2017

Sutures

Model: VICRYL RAPIDE™ (Polyglactin 910) SUTURE

MHRA reference: 2017/009/005/701/002

Hain Lifesciences GmbH

05 September 2017

IVDs, viral microbiology

GXT NA extraction kit

MHRA reference: 2017/009/006/701/011

Immucor: Capture-R® Ready-ID®; / 0066204 and 0066214

20 February 2017

IVDs, immunology

MHRA reference: 2017/009/006/291/002

Medtronic: DBS Lead Kit for Deep Brain Stimulation

August 2017

Implants, active, leads, neuro

Model: 3387, 3389, 3391

MHRA reference: 2017/003/020/291/021

Mentor: Siltex Round Ultra High Profile Gel Breast Implant

922232

Implants, breast

MHRA reference: 2017/008/031/701/017

Olympus: Working insert; Bridge

1 September 2017

Endoscopes, flexible

Model: A20975A (Working insert, with ramp, one way), A20976A (Bridge, one way), A20977A (Bridge, two way)

MHRA reference: 2017/008/025/701/010

Philips: Mobile Detector Holder

14 July 2017

X Ray, digital acquisition systems

Model: 9890-010-88152

MHRA reference: 2017/009/004/291/004

Radiometer: S7745 AUTOCHECK5+ LEVEL 2

FAN 915-370

IVDs, extra laboratory testing

Model: AUTOCHECK 5+

MHRA reference: 2017/009/004/291/024

SMS Technologies

14 August 2017

Anaesthetic & breathing, medical gas pipelines

Model: 1359808 Medical Nitrous Hose

MHRA reference: 2017/003/010/401/018

Published 11 September 2017