Field Safety Notices - 21 - 25 November 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 21 November - 25 November 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
Acutronic Medical Systems AG: fabian HFO and fabian evolution
15 November 2016
Lung ventilators
Model: 7200, 7200J, 7201, 7250, 7250.
MHRA reference: 2016/011/024/299/021
Alere
29 August 2016
Coagulation
Model: INRatio and INRatio2 monitors and test strips
MHRA reference: 2016/004/019/294/001
APELEM: Platinum dRF
18 November 2016
X Ray, General
MHRA reference: 2016/011/024/701/013
Biomet: Optipac @ Bone Cement
15 November 2016
Bone, cement and tools
MHRA reference: 2016/011/021/701/002
Bosch + Sohn
13 October 2016
Monitors, blood pressure
Model: 24h Ambulatory blood pressure monitor
MHRA reference: 2016/011/008/299/003
Domain Surgical: FMsealer Open Shears
27 October 2016
Surgical, diathermy
Model: FM3001
MHRA reference: 2016/011/018/601/010
Greatbatch: Offset Reamer Handle
3004976965-10/10/16-003-R
Surgical Instruments, non-articulated cutting
Model: T5766
MHRA reference: 2016/011/022/701/022
Handicare: Carina35OEM Carina 35OEML Carina 3SOEE
20 July 2016
Hoists and slings
Model: 60600011, 60600012, 60600009
MHRA reference: 2016/007/022/299/009
Invacare: Birdie
13 September 2016
Hoists and slings
Model: Birdie all models
MHRA reference: 2016/008/031/291/012
Maquet: Maquet Heater and Maquet Heater/Cooler Systems
15 November 2016
Blood/fluid warming systems
Model: HU35
MHRA reference: 2016/011/023/701/012
Radiometer Medical: AQURE system
FAN 915-358
IVDs, extra laboratory testing
Model: AQURE system
MHRA reference: 2016/011/018/291/009
Roche Diagnostics: Please see below under "Accessories"
15 November 2016
IVDs, extra laboratory testing
Model: cobas b 123 <3> POC system /cobas b 123 <4> POC system
MHRA reference: 2016/011/017/701/011
Smith & Nephew: Modular Neck Hip Prostheses
R-2016-48
Joint prosthesis, hip
MHRA reference: 2016/011/017/701/007
Smith & Nephew: Reflection Dead Blow Mallet
16 November 2016
Surgical devices, non-powered
MHRA reference: 2016/011/018/701/004
Siemens:IMMULITE 1/1000 IMMULITE 2000 PSA
November 2016
IVDs, immunology
MHRA reference: 2016/011/021/601/009
Siemens: EMIT® Ethosuximide assay
22 November 2016
IVDs, bacteriology
Model: 6E119UL
MHRA reference: 2016/011/023/601/002
Sunrise Medical: Trophy
October 2016
Scooters, powered
MHRA reference: 2016/001/026/292/023
Teleflex Medical: Visistat Skin Stapler 35 Wide (35W)
21 November 2016
Staples and staple guns
Model: 528235
MHRA reference: 2016/011/022/299/016
Völker GmbH:Nursing beds 2080, 2082, S 280, S 282
IT1019961
Beds and accessories
Model: 2080, 2082, S 280, S 282
MHRA reference: 2016/005/025/299/014
Xiros: Infinity-Lock implant set and disposable instrument se
22 November 2016
Orthopaedic surgical instruments - insertion/extraction tools
Model: 102-1088 and 202-1088
MHRA reference: 2016/011/022/601/005