Field Safety Notice - 02 to 06 April 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 April 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
Arcoma: 0180 Intuition / 0072 Precision
16 March 2018
X Ray, digital acquisition systems
Model: 0180 / 0072
MHRA reference: 2018/003/029/701/016
Arjo: Entroy
4 April 2018
Hoists and slings
Model: GAB1000-01 and GAB1000-11
MHRA reference: 2018/003/012/601/006
Balt Extrusion: ECLIPSE 2L and COPERNIC2L
03 January 2017
Vascular cannula and catheters
MHRA reference: 2017/010/012/291/032
Buhlmann Laboratories: IBDoc, component: CalApp Reader (software)
12 March 2018
IVDs, clinical chemistry
MHRA reference: 2018/003/027/291/014
Becton Dickinson: BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
09 April 2018
IVDs, specimen receptacles
MHRA reference: 2018/004/005/291/012
Depuy Synthes GmbH: Epoca Revision Set
26 March 2018
Orthopaedic surgical instruments - Insertion/extraction tools
Model: 03.401.072 & 03.401.077
MHRA reference: 2018/003/028/291/008
DIDACTIC S.A.S.: Infusion sets
31 January 2018
Infusion & transfusion, administration sets
MHRA reference: 2017/012/013/000/003
Ethicon: 5mm ENDOPATH® XCEL™ Bladeless Trocars with Optiview Technology
5mm ENDOPATH® XCEL™ Trocars - VOLUNTARY RECALL
Surgical instruments, minimal access
MHRA reference: 2018/003/023/478/029
Ethicon: 5mm ENDOPATH® XCEL™ Trocars with Optiview Technology
26 March 2018
Surgical Instruments, Minimal Access
MHRA reference: 2018/004/005/291/008
GE Healthcare: Lunar Prodigy
April 2018
Bone Densitometer System
MHRA reference: 2018/004/004/291/018
LivaNova: PLATINIUM VR
16 March 2018
Implants, active, defibrillators
Model: VR 1240, DR 1540, CRT-D 1741, SonR CRT-D 1841, 4LV CRT-D 1744, 4LV SonR CRT-D 1844
MHRA reference: 2018/003/019/291/005
Phadia AB: EliA Intrinsic Factor Well
FSN2018-02
IVDs, immunology
Model: 14-5668-01
MHRA reference: 2018/003/028/601/008
Richard Wolf GmbH: TUBE SET FOR TEM
26 March 2018
Suction equipment
Model: 4170.801
MHRA reference: 2018/003/029/701/003
Rocket Medical: R55990-ISO-6
28 March 2018
Cerebrospinal fluid drainage, external
MHRA reference: 2018/004/003/601 /004
Siemens Healthcare Diagnostics: Dimension / Dimension VISTA
March 2018
IVDs, clinical chemistry
MHRA reference: 2018/003/029/601/003
Siemens Medical Solutions (Siemens Healthineers): Acuson SC2000 Ultrasound System
April 2018
Ultrasound, imaging
10433816
MHRA reference: 2018/004/003/601/009