Field Safety Notice - 5 to 9 February 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 February 2018
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
Aesculap (B BRAUN): STRAUSS PENIS CLAMP 130MM
1 February 2018
Surgical instruments, articulated holding
STRAUSS PENIS CLAMP 130MM EF401R
MHRA reference: 2018/002/001/701/017
Boston Scientific: EMBLEM™ S-ICD Programmer
September 2017
Implants, active, defibrillators
Model: 3200
MHRA reference: 2017/001/010/299/013
Brainlab: ExacTrac
25 January 2018
Radiotherapy
MHRA reference: 2018/002/007/291/009
Carl Zeiss Meditec AG
05 February 2018
Implants, non-active, intraocular
Model: 611P 19.5D CT Lucia
MHRA reference: 2018/002/002/000/011
Harvest Healthcare
25 January 2018
Mattresses - active/passive and overlays
Model: mattress pumps
MHRA reference: 2017/011/015/291/041
Hitachi
January 2018
Magnetic resonance, equipment & accessories
Model: OASIS
MHRA reference: 2018/002/006/000/002
Intersurgical (Updated Version)
09 January 2018
Resuscitators
Model: BVM Manual Resuscitation Systems
MHRA reference: 2017/012/022/291/023
Inova Diagnostics: QUANTA Lyser® 240
26 January 2018
IVDs, clinical chemistry
Model: GS0242
MHRA reference: 2018/002/005/601/008
Olympus Corporation: URF-V2/URF-V2R flex
08 February 2018
Endoscopes, flexible
Model: URF-V2/URF-V2R
MHRA reference: 2018/001/030/000/008
Olympus Medical Systems: URETERO-RENOFIBERSCOPE - URF-P6/URF-P6R
08 February 2018
Endoscopes, flexible
MHRA reference: 2018/001/030/000/007
Richardson Healthcare: Plus Dressing Towel
31 January 2018
Basic dressings, absorbents, swabs, procedure packs
Model: 958008
MHRA reference: 2018/001/031/601/011
Smith & Nephew: LEGION HK DISTAL FEMORAL WEDGE SZ5 5MM
01 February 2018
Joint prosthesis, knee
MHRA reference: 2018/002/005/701/018
Synergy Health UK Limited: Attached list has name, lot, mfd & expiry dates
12 September 2017
Central sterilisation services materials
MHRA reference: 2017/009/021/291/015
Vircell: BORRELIA VIRCLIA® IgG MONOTEST
26 January 2018
IVDs, bacteriology
MHRA reference: 2018/002/005/291/019