Field Safety Notice - 21 to 25 August 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 August 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
BIOMERIEUX
18 August 2017
IVDs, bacteriology
Model: Mueller Hinton E Agar (MHE)
MHRA reference: 2017/008/024/291/001
Cook Medical: Central venous catheter set heparin coated triple lumen polyurethane, central venous catheter set triple lumen polyurethane, central venous catheter tray triple lumen polyurethane
04 August 2017
Vascular cannula and catheters
Model: N/A
MHRA reference: 2017/008/009/701/012
FUJIFILM: FUJIFILM ultrasonic mini probe
FSN 20170501
Endoscopes, flexible
Model: FUJIFILM Ultrasonic mini probe PB2020-M
MHRA reference: 2017/008/018/121/017
Philips: Allura Xper R9 and Azurion R1.1
11 August 2017
X Ray, fluoroscopy systems
Model: Allura Xper R9 and Azurion R1.1
- 722063 (Azurion 3 M12)
- 722064 (Azurion 3 M15)
- 722065 (Allura R9 7 M12)
- 722066 (Allura R9 7 M20)
- 722078 (Azurion 7 M12)
- 722079 (Azurion 7 M20)
MHRA reference: 2017/008/017/121/012
Philips
June 2017
ECG
Model: M1783A/M5526A Sync Cables & 989803195641 ECG Out Cables
MHRA reference: 2017/008/021/071/002
SAE Afikim Electric Wheelchairs: TGA Breeze S4 / TGA Breeze S3 (UK product names)
28 July 2017
Scooters, powered
Model: Afiscooter
MHRA reference: 2017/008/018/121/005
Siemens
7 August 2017
X Ray, fluoroscopy systems
Model: All artis systems with wireless foot switch
MHRA reference: 2017/008/018/601/005
Spectranetics: Bridge™ Occlusion Balloon
17 August 2017
Vascular cannula and catheters
Model: 590-001
MHRA reference: 2017/008/017/701/010
Stryker
April 2017
Osteosynthesis, Bone Screws
Model: Standard Lag Screw Omega
MHRA reference: 2017/004/019/299/010
Thermo Fisher: Thermo Scientific™ RemelTM Wellcolex™ Colour Shigella
17 August 2017
IVDs, Bacteriology
Model: R30858401
MHRA reference: 2017/008/022/601/001
Vygon: XRO Umbilical Catheter 37cm 3.5fg
7 August 2017
Vascular cannula and catheters
Model: 00027003
MHRA reference: 2017/008/002/601/002
Zimmer
09 August 2017
Joint prosthesis, knee
Model: Versys Beaded Hip Stem and Segmental Knee
MHRA reference: 2017/008/010/701/004