Field Safety Notices - 6 February - 10 February 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 6 February - 10 February 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

Bausch + Lomb: LazerEdge Knifes

18 October 2016

Surgical instruments, non-articulated cutting

MHRA reference: 2016/010/013/291/002

Boston Scientific: AngioJet® Ultra 5000A Console Foot Switch

7 February 2017

Vascular cannula and catheters

MHRA reference: 2017/002/008/291/012

Carl Zeiss Meditec: CT ASPHINA

1 February 2017

Implants, non-active, intraocular

Model: 409MP 20.0D

MHRA reference: 2017/002/008/701/009

Clinical Innovations: Kiwi Omni Vacuum Delivery System

16 January 2017

Surgical equipment, miscellaneous

Model: VAC-6000M

MHRA reference: 2017/002/006/701/005

Cook Medical: Flexor Radial Access Set

06 February 2017

Vascular cannula and catheters

MHRA reference: 2015/011/018/292/003

Covidien: Valleylab™ Laparoscopic Handset Four-Function

2 February 2017

Surgical, diathermy

Model: Valleylab

MHRA reference: 2017/002/001/701/015

Greatbatch Medical: Standard Offset Cup Impactor

3004976965-07/28/2016-003-C

Orthopaedic surgical instruments - impacting tools

Model: T15949, T17238; T9954; T9955; T8468; T11506; T10281; T8044; T17203; T8177; T16934; T11340; T8043; T17321; T15311; T17650; T8143; T14384; T16661; T9316; T13642; T10753; T9348; T13480; T10243; T11209; T10861; T16427; T9894; T12861; T8088; T16611; T9360; T13344; T13722; T7821; T10287; T8042; T17703; T6318; T8333; T9747; T8487; T8184; T9196; T12699

MHRA reference: 2017/002/003/299/002

Hospira: Plum 360 Infusion pump

30 January 2017

Infusion systems

Model: Plum 360 (30010)

MHRA reference: 2017/001/013/299/010

John Reid & Sons (Structsteel): Orthopaedic Leg Trolley

29 November 2016

Walking aids, walking frames

Model: K9

MHRA reference: 2016/011/010/291/010

Olympus: Video telescope "ENDOEYE HD II", 10 mm, 0° and 30°

3 February 2017

Endoscopes, rigid

Model: WA50040A (0°), WA50042A (30°)

MHRA reference: 2017/001/027/701/016

Philips: Philips Efficia CMS200 Central Monitoring System

December 2016

Monitors, patient

Model: 863352 (CMS200)

MHRA reference: 2017/002/006/291/004

Roche: See below under "Accessories"

31 January 2017

IVDs, viral microbiology

Model: cobas ® HIV-1 Test for use on the cobas ®4800 system (Cat. No. 06979599190) GMDN Code: 30768 Nomenclature Text: HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) - cobas® HBV Test for use on the cobas ® 4800 system (Cat. No.06979564190) GMDN Code: 48307

MHRA reference: 2017/002/002/701/016

Roche Diagnostics: TSH

03 February 2017

IVDs, clinical chemistry

Model: 11731459122

MHRA reference: 2017/002/003/701/012

Samsung: Ultrasound

FSCA-WS80A-161122003

Ultrasound, imaging

Model: WS80A

MHRA reference: 2017/001/026/299/003

Siemens: ADVIA Centaur XPT

February 2017

IVDs, clinical chemistry

MHRA reference: 2017/002/007/601/003

Siemens: Radiotherapy

TH008/16/S

Radiotherapy

Model: Mevatron (Artiste), Primus, Oncor

MHRA reference: 2017/002/002/601/001

Siemens: Axiom Artis

24 January 2017

X-ray, fluoroscopy systems

MHRA reference: 2017/002/003/601/020

Siemens: ADVIA 560 Hematology System

December 2016

IVDs, haematology

Model: SMN 11170842

MHRA reference: 2016/010/024/601/006

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