Field Safety Notice - 26 to 30 March 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 26 March to the 30 March 2018


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

Alere Technologies: Alere Afinion 2

March 2018

IVDs, clinical chemistry

MHRA reference: 2018/003/026/701/018

Biomet Orthopaedics LLC: Comprehensive Distal Humeral Body

19 March 2018

Joint Prosthesis, Shoulder

MHRA reference: 2018/003/023/291/012

CareFusion: Pressure Extension Set

February 2017

Infusion & transfusion, administration sets

Model: 72947NE, 72948NE, 72949NE, 72951NE & 72987NE

MHRA reference: 2017/003/014/291/011

Dako Denmark A/S: Monoclonal Mouse, Anti-Pneumocystis J. & Anti Huma


IVDs, Immunology

MHRA reference: 2018/003/026/478/005

Depuy Synthes: Flex Arm

21 March 2018

Surgical devices, non-powered

Model: Flex Arm 03.612.010

MHRA reference: 2018/003/028/291/012

Fannin: Columbia Blood Agar

27 March 2018

IVDs, bacteriology

Model: W11050

MHRA reference: 2018/003/027/601/003

Hitachi: cobas 8000 modular analyzer cobas e801 module

March 2018

IVDs, viral microbiology

Model: 07682913001

MHRA reference: 2018/003/023/478/028

Iris Diagnostics, a Division of Iris International, Inc.: iQ200 Series Urine Microscopy Analyzer

15 March 2018

IVDs, Clinical Chemistry

MHRA reference: 2018/003/022/601/019

Mast Group Ltd: Mast Uri System

22 March 2018

IVDs, Bacteriology

MHRA reference: 2018/003/022/601/009

Medtronic:Bellco MICROPLAS plasmafilters

March 2018

Dialysis, haemodialysis

MHRA reference: 2018/003/027/291/017

Philips Healthcare: Allura Xper / UNIQ

13 March 2018

X ray, fluoroscopy systems

Model: Allura Xper FD10 Allura Xper FD10 722003, Allura Xper FD10/10 722005, Allura Xper FD20 722006, Allura Xper FD20 Biplane 722008, Allura Xper FD10 722010, Allura Xper FD10/10 722011, Allura Xper FD20 722012, Allura Xper FD20/10 722013, Allura Xper FD10 OR table 722014, Allura Xper FD20 OR table 722015, Allura Xper FD10/10 OR table 722019, Allura Xper FD20 Biplane OR table 722020, Allura Xper FD10 ORT 722022, Allura Xper FD20 ORT 722023, Allura Xper FD10/10 ORT 722024, Allura Xper FD20/20 ORT 722025, Allura Xper FD10 722026 722026, Allura Xper FD20/10 722027, Allura Xper FD20 722028, Allura Xper FD20/10 722029, Allura Xper FD10 ORT 722033, Allura Xper FD10/10 ORT 722034, Allura Xper FD20 ORT 722035, Allura Xper FD20/10 ORT 722036, Allura Xper FD20/20 722038, Allura Xper FD20/20 ORT 722039, Allura Xper FD20/15 722058, Allura Xper FD20/15 ORT 722059

MHRA reference: 2018/003/027/291/004

Southwest Technologies: Elastogel Hypothermia Products

28 December 2017

Circulating-fluid whole-body cooling system control unit

Model: CAP610, CAP610LV, TM7008, TM7008LV, SL3000, SL3000LV

MHRA reference: 2018/003/026/601/003

Stryker: ETS. Hip endoprosthesis Head

March 2018

Joint prosthesis, hip

MHRA reference: 2018/003/021/291/018


27 March 2018

Breathing system components

Model: VKC2160, VKC21603, VKC2210, VKC22103, VKC221036, VKC221038, VKC2210386, VKC22106, VKC221069, VKC22107, VKC22108, VKC22109, VKC2260, VKC22606, VKC227, VKC22701356, VKC2270156, VKC22703, VKC227036, VKC227101, VKC2271013, VKC2271018, VKC2271218, VKC22712183, VKC22712186, VKC227121863, VKC2271418, VKC22714183, VKC22714186, VKC227141863, VKC22716, VKC2271603, VKC22716036, VKC227161, VKC2271613, VKC2271616, VKC2271618, VKC22716183, VKC22716186, VKC227161863, VKC227166, VKC2276

MHRA reference: 2018/003/028/601/003

Wright Medical Technology: Valor Nail

March 2018

Osteosynthesis, Nails

Model: 415101020R and 415101115R

MHRA reference: 2018/003/021/291/021

Published 3 April 2018