Field safety notices - 16 to 20 July 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 16 June to 20 July 2018.

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

Abbott Laboratories: ARCHITECT c4000 / c8000 / c16000

17 July 2018

IVDs, clinical chemistry

MHRA reference: 2018/007/019/291/012

BioMérieux: VIDAS CA 15-3

13 July 2018

IVDs, clinical chemistry

MHRA reference: 2018/007/016/701/012

Cantel Medical: SureStore

16 July 2018

Endoscopes, flexible

MHRA reference: 2018/006/026/081/010

DiaMed (Bio-Rad): IH-Com Kit Fullversion and IH-Com Kit for Reader

11 July 2018

IVDs, blood transfusion

MHRA reference: 2018/007/012/701/030

GCMedica Enterprise: Frazier Suction Handle

23 January 2018

Surgical equipment, miscellaneous

MHRA reference 2018/007/019/291/018

Geratherm Medical: Geratherm Patient Warming System UniqueTemp°

Recovery, Recovery Set 1; UniqueTemp° Pflegeset1

06 July 2018

Heating, patient, electrical pads & blankets

MHRA reference: 2018/003/008/291/006

Guangzhou Sunray Medical Apparatus: Maternal and Fetal Monitor SRF618X9

13 July 2018

Monitors, foetal

MHRA reference: 2018/007/006/291/007

Mast Group: Mast Uri Plates

Ciprofloxacin 0.5mg/L Plate, MPM-CIP0.5,

IVDs, bacteriology

Model: MPM-CIP0.5

MHRA reference: 2018/007/018/601/004

Medcomp: Multiple-list attached

13 July 2018

Vascular cannula and catheters

MHRA reference: 2018/007/019/291/019

Medtronic: Vectris™ Lead Kits

July 2018

Implants, active, leads, neuro

Model: 977D160, 977A290, 977A160, 977A175, 977A190, 977A260, 977A275, 977A290

MHRA reference: 2018/007/016/291/018

MicroPort: PLATINIUM

12 July 2018Implants,

Active, defibrillators

Model: PLATINIUM VR 1210, VR 1240, DR 1510, DR 1540, CRT-D 1711, SonR CRT-D 1811, CRT-D 1741, SonR CRT-D 1841, 4LV CRT-D 1744, 4LV SonR CRT-D 1844

MHRA reference: 2018/007/019/291/003

NeoTract (Teleflex): UroLift System

11 July 2018

Implants, non active, urology devices

MHRA reference: 2018/007/016/291/008

Philips Healthcare: Philips SureSigns VS & VM Monitors, and View Station (VSV)

SureSigns Vital Signs Monitors with software releases up to and including A.07.24

10 July 2018

Monitors, patient

MHRA reference: 2018/007/019/291/016

Sakura Finetek: AutoSection

29 June 2018

IVDs, cytopathology & histopathology

Model: AutoSection 5000

MHRA reference: 2018/007/017/291/004

Seers Medical: SEERS Medical

16 July 2018

Trolleys and chairs

Model: SM3484

MHRA reference: 2018/007/004/601/006

06 July 2018

Diagnostic measurement and monitoring

MHRA reference: 2018/007/013/291/010

Siemens Healthcare: IMMULITE 1/1000 IMMULITE 2000 PSA

November 2016

IVDs, clinical chemistry

Model: LKPS/L2KPS, LKPTS(D) & L2KPTS(D)

MHRA reference: 2016/011/021/601/009

Smith & Nephew: JELONET 15CM X 2M CTN 12

10 July 2018

Wound management

Model: 7415

MHRA reference: 2018/007/012/701/015

Teleflex (Arrow International): HANDS-OFF® Multi-Lumen Central Venous Catheter with Blue FlexTip® for use only with Arrow One-Piece

Percutaneous Sheath Introducer System

18 July 2018

Vascular cannula and catheters

MHRA reference: 2018/007/019/291/017

Tobii: Dynavox T10, Dynavox T15

3004959902

Disabled peoples' aids

Model: Dynavox T10, Dynavox T15

MHRA reference: 2018/007/016/291/003

Xion Medical: MATRIX DS; MATRIX DS2 / 350 010 882 HD

Safety instruction in Swiss Vk_20180622_16CAPA_2018_15

Endoscopes, flexible

MHRA reference: 2018/007/004/291/003

Zimmer: Connecting Bolt

13 July 2018

Osteosynthesis, bone screws

MHRA reference: 2018/007/016/291/001

Updates to this page

Published 23 July 2018