Field Safety Notice - 12 to 16 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 June 2017
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
AngioDynamics: Acculis Accu2i pMTA Applicator
June 2017
Therapy tissue ablation
Model: Acculis Accu2i pMTA Applicator
MHRA reference:
BELLCO S.r.l.: Formula, Formula Plus, Formula 2000, Formula 2000 Plus, Formula Therapy, Formula Domus
5 January 2017
Dialysis, haemodialysis
MHRA reference:
Balt Extrusion: SONIC microcatheter
30 May 2017
Vascular cannula and catheters
Model: All
MHRA reference:
Baxter Healthcare: Sharesource Connectivity Platform for use with the Homechoice Claria APD System
14 June 2017
Dialysis, peritoneal
Model: 5CGM01
MHRA reference:
Biomet Orthopaedics: Affixus Hip Fracture Nail
08 June 2017
Osteosynthesis, nails intramedullary
MHRA reference:
Boston Scientific: Extractor Pro RX-S Retrieval Balloon Catheter
June 2017
Surgical instruments, minimal access
MHRA reference:
Carestream: DRX-Revolution Mobile X-Ray System
29 May 2017
X Ray, digital acquisition systems
MHRA reference:
Draeger: Infinity Acute Care System (M540)
May 2017
Monitors, patient
Model: MK31501/MK31701/MK31722
MHRA reference:
Haemonetics: Cell Saver Elite Processing Kit (225 mL)
08 June 2017
Infusion & transfusion, autologous
MHRA reference:
Hain Lifesciences: Analyzer (software) for FluoroType HSV VER 1.0
02 June 2017
IVDs, viral microbiology
MHRA reference:
Livanova: Aortic Arch Cannula
June 2017
Vascular cannula and catheters
Model: NA-1116, NA-1137, NA-1206, NA-1207, NA-1208, NA-1337, RA-1126, RA-1127, RA-1136, RA-1137, RA-1138, RA-1206, RA-1207, RA-1208
MHRA reference:
Philips Healthcare: HeartStart MRx Defibrillator/Monitor
June 2017
Infusion & transfusion, autologous
Model: M3535A, M3536A
MHRA reference:
SHIMADZU Corporation: Fujifilm FDR Visionary Suite
SQBR-17009
X Ray, digital acquisition systems
MHRA reference:
Siemens: ADVIA Centaur Calibrator
June 2017
IVDs, clinical chemistry
MHRA reference:
Terumo: RF IK II, RF IK II M coat, Glidesheath Slender
May 2017
Vascular cannula and catheters
Model: See ANNEX 1 of FSN
MHRA reference:
Thoratec Corporation: HeartMate 3鈩� Left Ventricular Assist System
18 May 2017
Implantable ventricular assist devices
MHRA reference: