Field Safety Notices - 30 January - 3 February 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 30 January - 3 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

Atrium Medical

24 January 2017

Chest drains and accessories

Model: Thoracic catheters

MHRA reference: 2017/002/001/701/013

Bauch & Lomb: LazerEdge Knifes

1 February 2017

Surgical instruments, non-articulated cutting

Model: E7601

MHRA reference: 2017/002/001/701/014

Benson Viscometers

26 January 2017

IVDs, haematology

Model: BV200 Mk3

MHRA reference: 2017/001/030/299/001

Biomet: Oxford tibial resect body tube

16 January 2017

Orthopaedic surgical instruments - measuring tools

MHRA reference: 2017/001/018/291/040

Brainlab: iPlan RT Dose / iPlan RT

23 November 2016

Radiotherapy planning and verification systems

Model: iPlan RT Dose / iPlan RT; BrainSCAN (end-of-life)

MHRA reference: 2016/012/012/701/022

Brainlab: Brainlab Offset Cup Impactor Universal

22 December 2016

Orthopaedic surgical instruments - Impacting tools

Model: 52856, 52856A

MHRA reference: 2017/002/001/291/016

Cardiolex: Patient cable grabber (part of EC Sense)

30 January 2017

ECG

Model: Patient cable grabber

MHRA reference: 2017/002/001/291/026

Codman: Neurovascular embolization coil Neurovascular Embolization Coil Detacher

31 January 2017

Implants, non-active, embolisation products

Model: See "Attachment 1 - Catalogue numbers - commercial name_brand name_make

MHRA reference: 2017/002/002/299/006

CuraMedical: Curatamp

3 January 2017

Implants, non-active, vascular haemostasis device

Model: CT-140

MHRA reference: 2017/002/001/291/007

Dräger: Evita Infinity V500, Babylog VN500, Evita V300

January 2017

Lung ventilators

MHRA reference: 2017/002/001/291/023

GE Medical: Discovery MR450 1.5T narrow bore 1.5T non-GEM

FMI 60913

Magnetic resonance, equipment & accessories

Model: Discovery

MHRA reference: 2017/002/002/299/010

Medtronic: Medtronic Strata™ II/Strata™ NSC Valves (including Burr Hole and Lumbar Peritoneal [LP])

30 January 2017

Implants, non-active, hydrocephalus shunts

Model: 23042, 27739, 27740, 27788, 27794, 27812, 27814, 27815, 27816, 27817, 27818, 27819, 27820, 27821, 27822, 27823, 27824, 27825, 27827, 27922, 42335, 42355, 42365, 42836, 42856, 42866, 44420, 44421, 44430, 44465, 46070, 46075, 46080, 46085, 46655, 46665, 46836, 46856, 46866, 46871, 46876, 46881, 46886, 92355, 92365, 92856, 92866, 96655, 96665

MHRA reference: 2017/001/030/291/010

Philips: IntelliSpace Portal V6.5/Spectral Diagnostic Suite

14 November 2016

Computed tomography

Model: 8810051

MHRA reference: 2016/012/008/299/004

Roche: Anti-HAV

26 January 2017

IVDs, clinical chemistry

MHRA reference: 2017/001/030/701/014

Siemens: IMMULITE 2000/IMMULITE 2000 XPi Sex Hormone Binding Globulin (SHBG)

January 2017

IVDs, clinical chemistry

Model: L2KSH2 - SMN#: 10381198

MHRA reference: 2017/002/001/601/003

Smith & Nephew: Secura Protective Cream Z10 78g (CE)

31 January 2017

Barrier creams & sprays

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

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