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
Shenzhen Med_Link Elelctronics: Temperature Probe General Purpose 9F
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