Field Safety Notice - 13 to 17 November 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 November 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

Beckman Coulter: DxH 500

14 November 2017

IVDs, haematology

Model: DxH 500; Not applicable

MHRA reference: 2017/011/015/601/003

Blatchford: Kato Seat

October 2017

Supportive seating

MHRA reference: 2017/002/027/401/016

Fresenius: Freka Intestinal Tubes ENFit

15 November 2017

Feeding systems and tubes

Model: 7755646 and 7755647

MHRA reference: 2017/011/001/291/001

GE Healthcare: Millennium VG, Discovery VH, VariCam

GEHC Ref 40874

Nuclear medicine, gamma camera systems & accessories

MHRA reference: 2017/011/014/228/001

Inspiration Healthcare: CosyCrib NeoNatal Nursing System

11 September 2017

Heating, patient, electrical pads & blankets

Model: CCS001 / CCS002

MHRA reference: 2017/009/005/601/005

Medtronic: SynchroMed® II Implantable Drug Pumps

November 2017

Implants, active, infusion pumps

Model: 8637-20, 8637-40

MHRA reference: 2017/011/016/291/018

PFM Medical: Nit-Occlud Implantation Sheath

19 July 2017

Vascular cannula and catheters

Model: 004580, 204580, 404580, 604580, 804580, 904580

MHRA reference: 2017/011/009/228/015

Philips: Brilliance iCT, Brilliance 64, Ingenuity Core, Ingenuity Core 128

1 November 2017

Computed tomography

Model: 728306, 728231, 728321, 728323

MHRA reference: 2017/011/016/291/012

SORG: Mio, Mio Move, Kika and Vector

24 October 2017

Wheelchairs, manual

MHRA reference: 2017/011/013/228/020

Siemens: SOMATOM Force, SOMATOM Definition AS, Edge, Flash

November 2017

Computed tomography

Model: 7740769, 8098027, 10430603, 10590000, 10742326

MHRA reference: 2017/011/013/601/009

Stryker: Stryker Slap Hammer, Non Threaded Impactor, Head Impactor

10 November 2017

Orthopaedic surgical instruments - insertion/extraction tools

Model: 6541-4-803, 2101-0130, 4842-2000

MHRA reference: 2017/011/010/601/013

Thermofisher Scientific: ThermoScientific Remel BactiStaph Latex Kits

9 November 2017

IVDs, bacteriology

Model: R21143 / R21144

MHRA reference: 2017/011/010/601/016

Zimmer Biomet

09 November 2017

Joint prosthesis, knee

MHRA reference: 2017/011/013/228/018

Zimmer Biomet

13 November 2017

Bone cement and tools

Model: Bone Cement

MHRA reference: 2017/011/015/291/035

Zimmer Biomet: Specific Hip and Trauma instruments

27 September 2017

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2017/010/003/701/010

Updates to this page

Published 20 November 2017