Field safety notices - 23 to 27 March 2015

List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 March 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

Axis-Shield Diagnostics: Axis-Shield liquid stable (LS) 2-part homocysteine reagent

20 March 2015

Device description: IVDs, clinical chemistry

Model: FHRW & FHBC variants

MHRA reference: 2015/003/023/601/006

Bard Peripheral Vascular: ConQuest PTA balloon dilatation catheter

FA2015-02

Device description: vascular cannula and catheters

MHRA reference: 2015/003/025/701/002

Biomet: OXF.UNI C/LESS TIB TRAY LM E

23 March 2015

Device description: joint prosthesis, knee

MHRA reference: 2015/003/023/701/022

CooperSurgical: Wallach LL100 cryosurgical system

13 March 2015

Device description: surgical, cryogenic

Models: 900019-70 900019-70 900019-70 900019-70 900019-70 900019-70 900019-70 900019-70 900019-70

MHRA reference: 2015/003/025/701/005

Covidien: Trellis™ 8 peripheral infusion system

23 March 2015

Device description: vascular cannula and catheters

Model: Trellis 8

MHRA reference: 2015/003/023/071/007

Dako: Dako Autostainer

Reference: CAPA00475

Device description: IVDs, cytopathology and histopathology

MHRA reference: 2015/003/019/181/006

Dameca: Siesta i TS

24 March 2015

Device description: anaesthetic machines & monitors

MHRA reference: 2015/003/025/131/002

Elekta: Synergy XVI

Reference: 200 01 304 054

Device description: radiotherapy

MHRA reference: 2015/003/020/701/006

Intuitive Surgical: da Vinci® Xi™ surgical system

23 March 2015

Device description: endoscopes, rigid

Model: IS4000 surgical systems (patient side cart component)

MHRA reference: 2015/003/023/701/021

Microtek Medical: da Vinci Surgical System drapes

24 March 2015

Device description: surgical drapes, gowns, masks

Model: Affected product for Tear-Away Labels: 420015-03, 420022-02, 420256-01, 420258-01, 420279-03, 420291-03, 420290-03 Affected product for Cloudy / Waxy Appearance: 400015-03, 400016-04, 400027-04, 420015-03, 420017-03, 420022-02, 420026-01, 420256-01, 420258-01, 420273-02, 420279-03, 420281-02, 420290-03, 420291-03

MHRA reference: 2015/003/025/701/006

Natus Medical: neoBLUE® blanket phototherapy LED system

Reference: CAPA001888

Device description: Therapy, infant phototherapy

Model: i. 007299 neoBLUE® blanket LED Phototherapy System with Large blanket/pad EURii. 006254 neoBLUE® blanket LED Light Boxiii. 007300 neoBLUE® blanket LED Phototherapy System with Small blanket/pad EURiv. 007296 neoBLUE® blanket LED Phototherapy System with Large blanket/pad UK

MHRA reference: 2015/003/020/701/004

Nobel Biocare

19 March 2015

Device description: implants, dental

MHRA reference: 2015/003/020/701/001

Philips Medical Systems: accessory device – uninterruptible power supply (UPS)

9 March 2015

Device description: X-ray, digital acquisition systems

Model: All systems supported by UPS devices

MHRA reference: 2015/003/025/131/001

Philips Medical Systems: Juno DRF

3 February 2015

Device description: X-ray, fluoroscopy systems

Model: 709020

MHRA reference: 2015/003/017/081/010

Radiometer Medical: AQT90 FLEX

Reference: FAN 915-336

Device description: IVDs, haematology

MHRA reference: 2015/003/020/181/002

Siemens: Mevatron, Primus, Oncor, Artiste

Reference: TH016 14 S

Device description: radiotherapy

Models: 08139789, 05863472, 05857912, 07360717, 05857920, 04504200, 01940035, 05500371, 09822685, 09411588, 09822693, 08515520, 01940753, 01924500, 09401506, 09401407, 09401316, 09401746, 09401654.

MHRA reference: 2014/012/019/601/015

Sivantos: Unity 2, Unity 3

23 February 2015

Device description: audiometers

Model: NGP 70 T+NGP 70 BK

MHRA reference: 2015/003/020/601/005

Synthes

6 March 2015

Device description: spinal implants

Model: 388.550 & 388.656

MHRA reference: 2015/003/025/701/001

Uresil: Thoracic vent procedure tray

25 February 2015

Device description: surgical devices, non-powered

MHRA reference: 2015/002/009/081/012

Zimmer: Anatomical Shoulder™ handle for rasp

20 March 2015

Device description: surgical instruments, implant

MHRA reference: 2015/003/023/701/013

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