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

Published 29 August 2017