Field safety notices - 7 to 11 September 2015

List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 September 2015.


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

Aesculap AG: METHA titanium cone adapter (neck)

21 August 2015

Joint prosthesis, hip

Model: METHA NECK 12/14 - different CCD-angles; NC077T NC078T NC079T NC087T NC088T NC089T NC097T NC098T NC099T

MHRA reference: 2015/008/020/291/025

Alba Bioscience: ALBAclone Anti-Leb

7 September 2015

IVDs, blood transfusion

Model: Z217

MHRA reference: 2015/009/007/601/003

Baxter Healthcare SA: INFUSOR patient control module 0.5ml

September 2015

Infusion systems

MHRA reference: 2015/009/010/292/003

ConforMIS, Inc.: knee replacement systems: ConforMIS iTotal, iUni, and iDuo iJigs

6 September 2015

Surgical instruments, implant

MHRA reference: 2015/009/007/291/011

CME Limited: BodyGuard 575 PCA infusion pump

21 July 2015

Infusion systems

Model: 100-424PXS

MHRA reference: 2015/009/008/291/005

Dako Denmark A/S: EnVision FLEX


IVDs, cytopathology & histopathology

Model: K8000, K8002 and GV800

MHRA reference: 2015/009/007/292/001

Depuy Synthes: application instrument for sternal ZIPFIX

18 August 2015

Surgical instruments, implant

MHRA reference: 2015/009/007/299/004

Edwards Lifesciences LLC: ThruPort knot pusher and valve placement pack

26 August 2015

Surgical instruments, manipulating

Model: VPP (valve placement pack including KP1 knot pusher)

MHRA reference: 2015/009/007/299/001

GE Medical Systems LLC: GE Healthcare 3.0T MR systems

1 September 2015

Magnetic resonance, equipment & accessories

MHRA reference: 2015/009008/292/006

Impac Medical Systems, Inc: Monaco


Radiotherapy planning and verification systems

MHRA reference: 2015/009/010/292/010

iMDsoft Ltd: MetaVision suite, clinical information system

August 2015

Monitors, patient

MHRA reference: 2015/008/017/081/005

Leica Biosystems: Novocastra reagent

03 September 2015

IVDs, cytopathology & histopathology

Model: CD10-270-CE and CD10-270-CE-S

MHRA reference: 2015/009/003/601/006

Liko AB - Hill-Rom Lulea: Viking 300, Viking M, Viking L, Viking XL

Mod 1228

Hoists and slings

Model: Viking 300, Viking M, Viking L, Viking XL: 2040003, 2040004, 2040005, 2040015, 2040035.

MHRA reference: 2015/006/026/051/006

Pennine Healthcare: Endo-Modell Tibiaplateau sets und Ersatzteilsets

September 2015

Joint prosthesis, knee

Model: Total Knee Replacement 15-0027/11

MHRA reference: 2015/009/008/291/004

Roche Diabetes Care: Accu-Chek Insight


Infusion systems

Model: 00700006889 00700006889

MHRA reference: 2015/008/019/701/009

Roche Diagnostics: cobas b 123 sensor cartridge BG/ISE/GLU/LAC

04 September 2015

IVDs, extra laboratory testing

MHRA reference: 2015/009/008/701/014

Samsung Electronics Co: mobile digital X-ray GM60A


X-ray, digital acquisition systems

Model: GM60A-32S, GM60A-40S

MHRA reference: 2015/009/007/292/002

Published 11 September 2015