Field safety notices - 16 to 20 November 2015

List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 November 2015

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

Menarini: GlucoMen LX Sensor

November 2015

IVDs, self / home testing

MHRA reference: 2015/011/016/292/003

alamedics: ala octa

13 November 2015

Implants, non-active, intraocular

MHRA reference: 2015/011/016/291/002

bioMerieux: MYLA ® - all software versions

13 November 2015

IVDs, bacteriology

MHRA reference: 2015/011/016/292/005

Breas Medical: Home care ventilator

11 November 2015

Lung ventilators

Model: Vivo 60

MHRA reference: 2015/011/018/292/002

Christoph Miethke GmbH & Co.KG: proGAV | proGAV 2.0

18 November 2015

Implants, non-active, hydrocephalus shunts

MHRA reference: 2015/011/019/701/015

DePuy Orthopaedics Worldwide: Reach System Handle

November 2015

Surgical instruments, implant

Model: 950505154

MHRA reference: 2015/011/016/291/013

GERMITEC: ANTIGERMIX E1

12 November 2015

Sterilization methods, irradiation

MHRA reference: 2015/011/019/701/014

Infopia Co: HemoCue ® HbA1c 501

5 November 2015

IVDs, extra laboratory testing

Model: IGM-0026B

MHRA reference: 2015/011/019/181/002

Philips Healthcare Nederland B.V: Allura Xper, AlluraClarity, Allura CV, Allura Centron and UNIQ systems

26 October 2015

X-ray, fluoroscopy systems

Model: Various

MHRA reference: 2015/011/017/292/009

QIAGEN: artus C. trachomatis Plus RG & LC PCR Kits

6 November 2015

IVDs, bacteriology

Model: 4559263, 4559265, 4559063, 4559065, 4559267

MHRA reference: 2015/011/013/701/008

Siemens Healthcare : syngo X WP

19 October 2015

X-ray, general

Model: 10502522

MHRA reference: 2015/011/016/601/004

Siemens Healthcare Diagnostics: Stratus CS Acute Care diagnostics system

November 2015

IVDs, clinical chemistry

MHRA reference: 2015/011/012/601/002

Siemens Healthcare Diagnostics Inc: ADVIA Centaur; ADVIA Centaur XP

November 2015

IVDs, clinical chemistry

MHRA reference: 2015/011/018/601/002

Sorin Group Italia: Sterile Inspire custom pack

23 October 2015

Infusion & transfusion, heart lung circuits

MHRA reference: 2015/010/027/292/015

Spirit Healthcare: CareSens N glucose meters

12 November 2015

IVDs, self / home testing

MHRA reference : 2015/011/013/291/004

St. Jude Medical: Optisure dual coil defibrillation lead

4 November 2015

Implants, active, leads and electrodes

Model: LDA 220 Q52, LDA 220 Q58, LDA 220 Q65 and LDP 220 Q58

MHRA reference: 2015/011/017/299/004

Smith & Nephew: Birmingham HIP™ Modular Head 38MM~58MM Monoblock

16 November 2015

Joint Prosthesis, Hip

MHRA reference: 2015/011/018/701/012

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