Field safety notices - 18 to 22 January

List of field safety notices (FSNs) from medical device manufacturers from 18 January to 22 January 2016.


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

Baxter: Uromatic Tur admin set

January 2016

Infusion & transfusion, administration sets

MHRA reference: 2016/001/019/292/013

Baxter Healthcare SA: HomeChoice automated PD system and HomeChoice PRO automated PD system

January 2016

Dialysis, peritoneal

Model: R5C8320, 5C4474, 5C4471 and 5C8310

MHRA reference: 2016/001/015/292/007

GE Healthcare: Anaesthesia system


Anaesthetic machines & monitors

Model: Aespire 7900 Aespire View Aestiva 7900 Aestiva MRI Aisys Aisys CS2 Amingo & AvanceAvance CS2

MHRA reference: 2016/001/015/292/001

GE Healthcare: PRN 50-M+ digital writer



Model: Model 600‐23310‐10, GE part number 2062759-001

MHRA reference: 2016/001/019/292/019

GE Medical Systems: Optima XR220amx, Optima XR200amx, Brivo XR285amx

GEHC Ref 10906

X-ray, digital acquisition systems

MHRA reference: 2016/001/004/292/008

Immucor: Capture-R® Ready-ID®; Panocell-20®; Panocell-16®

18 January 2016

IVDs, Blood Transfusion

MHRA reference: 2016/001/019/292/009

Leica Biosystems Newcastle: Bond™ polymer Refine detection kit and Novolink™polymer detection systems

6 January 2016

IVDs, cytopathology & histopathology

Model: DS9800 and RE7280

MHRA reference: 2016/001/007/601/009

Leica Microsystems: surgical microscope

19 January 2016

Surgical equipment, miscellaneous

Model: various models

MHRA reference: 2016/001/021/292/033

Natus Medical Incorporated DBA Excel-Tech: Quantum amplifier


Monitors, patient

Model: Quantum

MHRA reference: 2015/012/015/291/009

Siemens Healthcare: ADVIA Centaur Enhanced Estradiol; Dimension Vista LOCI Estradiol; IMMULITE/IMMULITE 1000 Estradiol; IMMULITE 2000 Estradiol

January 2016

IVDs, clinical chemistry

MHRA reference: 2016/001/018/601/005

Smith & Nephew: LEGION screw-on hemi stepped tibial wedge

18 January 2016

Joint prosthesis, knee

MHRA reference: 2016/001/020/292/004

Varian: Eclipse™ treatment planning system H48

11 January 2016

Radiotherapy planning and verification systems

MHRA reference: 2016/001/019/701/002

Published 25 January 2016