Field Safety Notice - 16 to 20 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 October 2017.
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: Alinity i Processing Module
11 October 2017
IVDs, clinical chemistry
MHRA reference: 2017/010/013/701/028
Bard: BARD® MAX-CORE® Disposable Core Biopsy Instrument
FA2017-50
Surgical Instruments, Minimal Access
MHRA reference: [2017/010/012/601/002
Beckman Coulter: Access BR Monitor
12 September 2017
IVDs, clinical chemistry
MHRA reference: 2017/004/020/601/009](https://mhra.filecamp.com/public/file/2och-f5rp014a)
BIOMERIEUX
12 October 2017
IVDs, bacteriology
Model: BacT/ALERT® BPN Culture Bottle
MHRA reference: 2017/010/016/291/017
BIOMERIEUX: VITEK® 2 System
12 October 2017
IVDs, bacteriology
MHRA reference: 2017/010/017/291/006
BIOMERIEUX: VITEK® 2 Gram-Positive (GP) Identification (ID) Test Kit
17 October 2017
IVDs, bacteriology
MHRA reference: 2017/010/018/291/005
Coloplast: Duowire™ Bi-Flex
16 October 2017
Surgical instruments, minimal access
MHRA reference: 2017/010/019/000/001
CooperSurgical: 2MHz WATERPROOF OB PROBE
6 October 2017
Monitors, foetal
Model: SDW
MHRA reference: 2017/010/013/291/002
Diagnostica Stago: (STA) Néoplastine CI (Plus) 2 and 5
17 October 2017
Coagulation
MHRA reference: 2017/010/018/701/013
Fisher & Paykel: RT021 Catheter Mount
17 October 2017
Breathing systems components
Model: RT021
MHRA reference: 2017/010/012/291/005
Fisher & Paykel: RT443 Circuit Adult Homecare
17 October 2017
Breathing systems components
Model: RT443
MHRA reference: 2017/010/012/291/005
Manquet: HANAULUX 2000, HANAULUX 3000, XTEN series
September 2017
Lamps & lights
Model: HLX 2004-5 DF, HLX 3004-5 DF, XTEN DF
MHRA reference: 2017/009/026/291/011
Medivance: Arctic Sun® Temperature Management System
FA2017-14
Heating, patient, electrical pads & blankets
Model: Arctic Sun® Temperature Management System
MHRA reference: 2017/008/004/701/010
Permobil AB
6 October 2017
Wheelchairs, powered
Model: C300, C350, C400 and C500 with seats Corpus II, Corpus II LR, Corpus KB and Base Only
MHRA reference: 2017/009/004/701/002
Riverpoint Medical: Arena Alpha (OrthoButton AL)
11 October 2017
Ligaments, tendons and anchors
Model: D201028 (OBAL-80)
MHRA reference: 2017/010/012/601/004
Schiller
09 January 2017
ECG
Model: CARDIOVIT AT-102 plus 0.075000
MHRA reference: 2017/010/016/291/014
Siemens: DM FT4L, TSHL, SIRO DV CTNI, MMB, TSH
October 2017
IVDs, clinical chemistry
MHRA reference: 2017/010/018/601/002
St. Jude Medical: Implantable Pulse Generators (IPGs)
12 September 2017
Implants, active, stimulators, neuro
Model: Implantable Pulse Generators (IPGs)
MHRA reference: 2017/009/013/291/030
Surgical Innovations: Yelloport Plus
30 August 2017
Surgical instruments, minimal access
Model: YA512STSA
MHRA reference: 2017/010/014/601/001
Surgical Innovations: YelloPort 10.5/5.5 S/Use Flip-Top
29 September 2017
Surgical instruments, minimal access
Model: YelloPort 10.5/5.5 S/Use Flip-Top - 575019S
MHRA reference: 2017/010/016/601/006
Surgical Innovations: Yelloport 10.5/12.5 Valve Single-Use
10 October 2017
Surgical instruments, minimal access
Model: Yelloport 10.5/12.5 Valve Single-Use - 580004S
MHRA reference: 2017/010/016/601/008
Thermofisher Scientific: Oxoid Mueller – Hinton Agar (Prepared Media)
13 October 2017
IVDs, bacteriology
Model: PO0152A
MHRA reference: 2017/010/016/601/004