Field Safety Notice - 04 to 08 June 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 June 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
Acumed: ACUMED 3.5x12.00mm / 3.5x10.0mm Cortical Screws
30 May 2018
Osteosynthesis, bone screws
Model: CO-3120-S; CO-3100-S
MHRA reference: 2018/006/006/478/001
B Braun: Askina Calgitrol Paste, Askina Gel
25 April 2018
Wound management
MHRA reference: 2018/004/025/601/009
Bio-Rad: MRSASelect™II
04 June 2018
IVDs, bacteriology
MHRA reference: 2018/006/007/081/009
Charder electronic: Charder
ER11810003
Therapy, scales
Model: MHS2510-MHS2510I
MHRA reference: 2018/005/029/601/002
Coltene Whaledent: Unity Drill Assembly Unit, .021 Green
17 May 2018
Surgical power tools
MHRA reference: 2018/006/007/701/007
Eurogine
07 March 2018
Implants, non-active, contraceptive implants
Model: Ancora
MHRA reference: 2018/003/015/478/020]
GE Healthcare: T2100 Treadmill
FMI 30085
Diagnostic measurement and monitoring
MHRA reference: 2018/006/008/478/004
Maquet: VOLISTA StandOP, Triop and Access
14 May 2018
Lamps & lights
MHRA reference: 2018/005/021/478/006
Mast Group: Mast Uri Plates
05 June 2018
IVDs, bacteriology
Model: MPM-AUG32
MHRA reference: 2018/006/005/601/005
Medtronic: HeartWare™ HVAD™ System (Update)
June 2018
Implantable ventricular assist devices
Model: Controller - 1400, 1401, 1403, 1407, 1420 DC Adapter - 1435, 1440 AC Adapter - 1425, 1430 Battery Pack - 1650
MHRA reference: 2018/005/008/228/001
NEWRONIKA: HDCKIT
31 May 2018
Therapy, electrotherapy
MHRA reference: 2018/006/004/291/020
Newdeal (integra): HINTEGRA & HINTEGRA SENSITIVE
17 May 2018
Osteosynthesis, bone screws
Model: 03312S - 303314S - 303316S - 303320S - 303328S - 303330S - 303334S - 303338S - 303340S - 303342S 303512S - 303516S - 303520S - 303530S - 303534S - 303538S - 303540S - 303542S
MHRA reference: 2018/006/006/291/012
Philips Medical Systems: MobileDiagnost wDR
17 May 2018
X Ray, digital acquisition systems
Model: 712002, 712004
MHRA reference: 2018/006/004/478/012
QIAGEN: EZ1 DSP Virus Kit (48)
28 May 2018
IVDs, viral microbiology
MHRA reference: 2018/005/030/701/006
Siemens Healthcare: ARTIS pheno
24 May 2018
X Ray, fluoroscopy systems
MHRA reference: 2018/005/030/601/008
Leica: Leica M320
17 May 2018
Surgical equipment, miscellaneous
MHRA reference: 2018/005/022/478/021