Field Safety Notices - 1 - 5 August 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 1 - 5 August 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
Abbott Vascular: Absorb and Absorb GT1
27 July 2016
Implants, non-active, coronary artery stents
MHRA reference: 2016/008/004/291/001
Alcon Laboratories: AcrySof IQ IOL with ULTRASERT™ delivery system
29 July 2016
Implants, non-active, intraocular
MHRA reference: 2016/008/001/299/008
Beckman Coulter: DxH 500
27 July 2016
IVDs, haematology
MHRA reference: 2016/007/027/601/009
BIOMERIEUX: Etest Colistin CO 0.016-256
1 August 2016
IVDs, bacteriology MHRA reference: 2016/008/001/299/006
Esaote: MyLab Twice/Esaote/Esaote
10 March 2016 Ultrasound, imaging Model: 9706200000
MHRA reference: 2016/007/011/291/002
Esaote: Gscan Brio/Esaote/Esaote
18 April 2016 Magnetic resonance, equipment & accessories Model: 111002000
MHRA reference: 2016/007/011/291/001
Maquet: Fixture
19 July 2016
Operating table Model: 1002.65A0
MHRA reference: 2016/007/020/701/001
Medtronic: EnVeo R delivery catheter system
August 2016
Implants, non-active, cardiovascular heart valves
Model: ENVEOR-L
MHRA reference: 2016/008/004/299/003
Mölnlycke Health Care AB: ProcedurePak kits and trays containing umbilical clamps
28 July 2016
Surgical devices, non-powered
MHRA reference: 2016/008/005/701/009
Nobel Biocare: NobelParallel CC guided surgery kit
03 August 2016
Surgical devices, non-powered Model: 38072
MHRA reference: 2016/007/022/701/010
Physio-Control: LIFEPAK CR Plus AED and LIFEPAK EXPRESS AED
August 2016
Defibrillators, non-implantable Model: 3202359-XXX and 3202177-XXX
MHRA reference: 2016/008/003/299/011
Siemens AG: Assembly group table of Ysio, Ysio Max and Multix Fusion
UI XP022/16/S & UI XP023/16/S & UI XP026/16/S
X-ray, digital acquisition systems
Model: 10273106 and 10273107
MHRA reference: 2016/008/001/601/003
Siemens Healthcare Diagnostics: ADVIA Centaur PSA
July 2016
IVDs, clinical chemistry
Model: SMN 10310292, SMN 10310293
MHRA reference: 2016/008/001/601/001
Tem Innovations: ROTEM platelet cuvettes (art. No. 200188)
23 March 2016
IVDs, haematology MHRA reference: 2016/005/003/299/009