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
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