Field safety notices - 7 to 11 December 2015
List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 December 2015
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.
See more information on what an FSN is and why it’s important.
Latest FSNs
Abbott: Absorb and Absorb GT1 bioresorbable vascular scaffold system
7 December 2015
Implants, non-active, coronary artery stents
MHRA reference: 2015/012/002/291/003
Biomet Orthopaedics: A.L.P.S. 4.0mm cancellous locking screw
20 November 2015
Osteosynthesis, bone screws
MHRA reference: 2015/012/001/292/002
Biomet 3i UK, Ltd: LOCATOR® abutments (LOA002)
9 December 2015
Implants, dental
MHRA reference: 2015/012/010/292/016
Beckman Coulter: MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels
8 December 2015
IVDs, bacteriology
Model: B1017-201, B1017-211, B1017-214, B1016-161, B1016-172, B1016-174, B1017-202, B1017-206, B1016-152, B1016-164
MHRA reference: 2015/012/009/601/008
Boston Scientific: ACUITY™ lead delivery system guide catheters - ACUITY™ Pro
November 2015
Vascular cannula and catheters
MHRA reference: 2015/012/007/291/014
Ethicon: Gynecare Thermachoice III catheter
2 December 2015
Therapy tissue ablation MHRA reference: 2015/012/003/291/006
Elekta Impac Medical: MOSAIQ
FCA-IMS-0012 Radiotherapy
MHRA reference: 2015/012/007/291/009
Mast Group: Mast Augmentin 32μg 96 well pre-poured susceptibility test plate
C5668
IVDs, bacteriology
Model: MPM-AUG32
MHRA reference: 2015/012/008/601/005
Medasil Surgical Limited: Medasil airway (Guedel type)
CCR 181
Airway devices
MHRA reference: 2015/011/027/701/001
Molnlycke Health: ProcedurePak containing MeCoBo swabs
4 December 2015
Surgical devices, non-powered
MHRA reference: 2015/012/007/291/015
Pyng Medical: MATResponder tourniquet, MATCombat tourniquet
1 September 2015
Surgical equipment, tourniquets
MHRA reference: 2015/012/010/292/012
Siemens Healthcare: All applicable Siemens MR systems with superconducting magnets
3 December 2015
Magnetic resonance, equipment and accessories
MHRA reference: 2015/012/004/601/005
Synthes Selzach: SynReam medullary reamer head diameter 13.5mm
4 December 2015
Surgical instruments, implant
Model: 352.135
MHRA reference: 2015/012/009/292/003
Synthes Mezzovico: universal femoral nails
8 December 2015
Osteosynthesis, nails intramedullary
Model: 272.136, 274.220, 274.020, 274.130
MHRA reference: 2015/012/009/292/010
Venus Concept: Venus Versa
3 November 2015
Intense pulse light source
Model: VE102407
MHRA reference: 2015/011/009/292/010