Field Safety Notices - 20 - 24 June 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 20 - 24 June 2016

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

ArjoHuntleigh: Sara Combilize

June 2016

Hoists and slings

Model: APA1000-XX

MHRA reference: 2016/006/021/601/005

Covidien: Cytosponge™ Cell Collection Device

16 June 2016

Surgical instruments, minimal access

MHRA reference: 2016/006/016/291/011

D-tek: BlueDiver Dot kits; BlueDiver Quantrix kits

31 May 2016

IVDs, immunology

MHRA reference: 2016/006/016/291/009

Dialab: DIAQUICK HIV Triline; HCV; HBsAg Cassette

20 June 2016

IVDs, viral microbiology

MHRA reference: 2016/006/020/291/014

EIZO: RadiForce

DP-6bit_FSCA_2015-07-01_001

Monitors, patient

MHRA reference: 2015/008/011/081/005

Gambro: SOL.3.5LT. SOFTPAC C299

21 June 2016

Dialysis, haemodialysis

MHRA reference: 2016/006/022/291/001

GE Medical: Discovery MR750w 3.0T

FMI 60901

Magnetic resonance, equipment & accessories

Model: Discovery MR750w 3.0T 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5327625, 5911000-3

MHRA reference: 2016/006/017/291/007

Hangzhou Biotest Biotech: RightSign HIV 1.2.O Rapid Test Cassette RightSign HCV Rapid Test Cassette RightSign HBsAg Rapid Test Cassette

20 June 2016

IVDs, viral microbiology

MHRA reference: 2016/006/020/291/004

Lumenis: LightSheer DESIRE

25 March 2015

Therapy, lasers

Model: GA-1170000 - LightSheer Desire system; GA-1171030 - Hand Piece XC.

MHRA reference: 2016/003/009/291/008

Medtronic: Temporary Transvenous Pacing Lead 6416-100, 6416-140, 6416-200

16 June 2016

Pacemakers, externa

MHRA reference: 2016/006/016/291/001

Rocket Medical

20 June 2016

R51551

Model: R51551

MHRA reference: 2016/006/021/601/006

Roche: Accu-Chek Insight Tender

SB_RDC_2016_08

Infusion & transfusion, administration sets

Model: 06478069001, 06478085001, 06478093001, 06478107001, 06478115001, 06478239001, 06478247001, 06541836001, 06541844001

MHRA reference: 2016/006/022/291/003

Sirona Dental: Sirona / Nitram / Fona

1 June 2016

Sterilizers, steam (Autoclaves)

Model: DAC Universal (MK3)

MHRA reference: 2016/006/017/291/021

Sorin: Oxygenator Mounting Brackets

15 June 201

Blood/fluid warming systems

MHRA reference: 2016/006/021/291/012

TEC COM: TECOTHERM NEO

13 June 2016

Blood/fluid warming systems

MHRA reference: 2016/006/021/701/008

Xiros: Infinity-Lock

21 June 2016

Ligaments, tendons and anchors

MHRA reference: 2016/006/021/601/014

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