Field Safety Notices - 19 December - 23 December 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 19 - 23 December 2016

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

Agfa: NX 3.0

VR0000460

Picture Archiving and Communication System (PACS)

Model: Version 8950 (software)

MHRA reference: 2016/012/020/701/013

Bedfont Scientific: NObreath

06 December 2016

Diagnostic measurement and monitoring

MHRA reference: 2016/011/029/601/005

Elekta: Oncentra External Beam

December 2016

Radiotherapy planning and verification systems

Model: 170.730

MHRA reference: 2016/012/021/701/016

Hamamatsu: NanoZoomer

2 December 2016

IVDs, cytopathology & histopathology

Model: NanoZoomer -XR(L), -SQ, -S210, -S60

MHRA reference: 2016/012/020/291/027

Medtronic: SynchroMed® II Programmable Pump, N’Vision Application Card

December 2016

Implants, active, infusion pumps

Model: 8637-20, 8637-40, 8870

MHRA reference: 2016/012/019/291/012

nal von minden: NADAL hCG Pregnancy rapid test

12 December 2016

IVDs, extra laboratory testing

MHRA reference: 2016/012/015/701/010

Richard Wolf: Guide Wire Semislip L 150CM

07 December 2016

Surgical instruments, minimal access

Model: 4111000150

MHRA reference: 2016/012/015/701/007

Philips: Ingenia MR-OR

November 2016

Magnetic resonance, equipment & accessories

Model: 781437, 781438

MHRA reference: 2016/012/021/291/012

Philips: Allura Xper Systems and Allura Integris Systems

09 December 2016

X Ray, fluoroscopy systems

Model: 72247, 722043, 722001, 722002, 722003, 722005, 722006, 722008

MHRA reference: 2016/012/021/291/020

Stanmore: METS Modular Proximal Humerus System

20 December 2016

Joint prosthesis, shoulder

Model: Humerus Integral Shaft and Stem implant component (80mm stem length)

Humerus Integral Shaft and Stem implant component (100mm stem length)

MHRA reference: 2016/012/021/291/007

Synergy Health: DETEX

16 December 2016

Basic dressings, absorbents, swabs, procedure packs

Model: 30 x 30cm, 18ply, stitched and taped, 5 Tied, Double Wrapped.

MHRA reference: 2016/012/019/701/026

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