Field safety notices - 25 April to 29 April 2016
List of field safety notices (FSNs) from medical device manufacturers from 25 April to 29 April 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
Alcon Laboratories: LenSx Laser System
22 April 2016
Therapy, lasers
MHRA reference: 2016/004/022/299/017
B Braun Medical: DPO4000L DISPENSING PIN W/ ULTRASITE 412023
25 April 2016
Infusion & transfusion, connectors
MHRA reference: 2016/004/021/601/014
Bard: EnCor Biopsy Probe, Vertical
FA2015-51
Surgical instruments, minimal access
MHRA reference: 2016/004/022/601/008
BioFire Diagnostics: FilmArray Blood Culture Identification Panel-BCID
1604 FilmArray BCID Panel
IVDs, bacteriology
MHRA reference: 2016/004/022/701/014
Biomet: Tyvek pouch for various sports medicine and trauma products
01 April 2016
Central sterilisation services materials
MHRA reference: 2016/004/021/291/009
Biomet: Distal Plug
22 April 2016
Surgical instruments -impacting tools
MHRA reference: 2016/004/027/299/001
Carestream: CARESTREAM Image Suite
22 April 2016
Picture Archiving And Communication System (PACS) MHRA reference: 2016/004/022/299/014
Cook Medical: Beacon Tip Angiographic Catheters
2016FA0002
Vascular cannula and catheters
MHRA reference: 2016/004/027/299/008
Cook Medical: FluoroSet® Radiographic Tubal Assessment Set, Selective Salpingography Catheter with Beacon® Tip Kumpe Access Catheter
21 April 2016
Vascular cannula and catheters
MHRA reference: 2016/004/022/291/009
GE Medical
26 April 2016
X Ray, Fluoroscopy Systems
Model: Discovery IGS 730, Discovery IGS 740
MHRA reference: 2016/004/027/299/007
Optimed: Zelos PTA-balloon catheter
25 April 2016
Vascular cannula and catheters
MHRA reference: 2016/004/021/701/007
Oridion Medical 1987: Battery Pack Used with the Capnostream™20 and Capnostream™20p Patient Monitor.
25 April 2016
Monitors, patient
MHRA reference: 2016/004/022/299/001
Phadia: EliA CCP Positive Control
21 April 2016
IVDs, immunology
MHRA reference: 2016/004/026/601/003
Philips: IntelliSpace Portal
06 March 2016
Computed tomography
Model: IntelliSpace Portal 881001
MHRA reference: 2016/003/018/292/004
Philips Medical: Brilliance BR64 Ingenuity CT Ingenuity Core Ingenuity Core128 Brilliance iCT SP Brilliance iCT
19 April 2016
Computed tomography
Model: Brilliance BR64 (728231) Ingenuity Core (728321) Ingenuity Core128 (728323) Ingenuity CT (728326) Brilliance iCT SP – N/A Brilliance iCT – NCTC780
MHRA reference: 2016/004/026/291/010
Philips Medical: MobileDiagnost wDR
04 April 2016
X Ray, digital acquisition systems
Model: 712002
MHRA reference: 2016/004/026/291/009
Roche: AssayTip / AssayCup
26 April 2016
IVDs, clinical chemistry
MHRA reference: 2016/004/027/701/010
Spacelabs Healthcare: Xhibit Telemetry Receiver
28 March 2016
Monitors, patient
Model: 96280
MHRA reference: 2016/004/020/299/004
WEINMANN: OXYWAY
April 2016
Gas cylinders
Model: Several
MHRA reference: 2016/004/008/701/006
William Cook Europe
2016FA0002_WCE
Vascular cannula and catheters
MHRA reference: 2016/004/027/299/009