Field Safety Notice - 9 to 13 April 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 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
Becton Dickinson: BD Vacutainer® Push Button Blood Collection Set
15 March 2018
Storage & collection devices
MHRA reference: 2018/003/016/701/018
Biomet (Zimmer): ZNN and MDN Guide Wires
11 April 2018
Surgical instruments, minimal access
MHRA reference: 2018/004/012/291/003
Change Healthcare: McKesson Cardiology Hemo
12 March 2018
Monitors, patient
MHRA reference: 2018/004/009/291/001
Cook Medical: Rhapsody H-30® Holmium Laser System
02 April 2018
Therapy, lasers
MHRA reference: 2018/004/010/701/014
Covidien (Medtronic): LigaSure™ Exact Dissector, Nano-coated 20.6mm-21cm
March 2018
Surgical, diathermy
MHRA reference: 2018/003/027/478/008
Depuy Synthes GmbH: Synthes Sciatic Nerve Retractor
04 April 2018
Surgical instruments, articulated retracting
Model: 03.100.013 and 03.100.014
MHRA reference: 2018/004/009/291/033
EV3 (Medtronic): 300010, 300011, 300012, 300013 MindFrame CaptureTM LP
April 2018
Vascular cannula and catheters
Model: MindFrame CaptureTM LP
MHRA reference: 2018/003/012/478/003
Genicon: EZee Retrieval
29 March 2018
Surgical instruments, minimal access
Model: EZee Retrieval 550-000-000
MHRA reference: 2018/004/004/291/011
IRIDEX Corporation: TruFocus LIO Premiere
05 April 2018
Therapy, lasers
MHRA reference: 2018/004/005/601/010
LAP GmbH Laser Applikationen: APOLLOblue (24V)
29 March 2018
Therapy, lasers
MHRA reference: [2018/004/006/291/013]
Lockdown Medical: LD110 11cm Acromioclavicular (AC) Device
18 October 2016
Osteosynthesis, bone screws
MHRA reference: 2018/004/011/291/010
Medela AG: Medset CM
MIR182-18
Active wound management
Model: 001.0112
MHRA reference: 2018/004/004/601/003
Philips: T5, T10-NT, ACSNT, Intera 0.5T/1.0T, 1.5T, Achieva 1.5T, Multiva 1.5T, Ingenia CX 1.5T and Panorama 1.0T MR systems
March 2018
Magnetic resonance, equipment & accessories
Model: 78104, 78106, 78107, 78108,781072, 78107, 781074, 781076, 781078, 781101, 781102, 781103, 781104, 781105, 781106, 781107, 781108, 781160, 781170, 781171, 781172, 781173, 781174, 781175, 781176, 781178, 781195, 781196, 781250, 781260, 781261, 781262, 781283, 781295, 781296, 781343, 781346, 781382, 781487, 781488, 781492, 781495, 781496, 781497, 781498
MHRA reference: 2018/004/010/291/021
Philips Medical Systems Nederland BV: MultiDiagnost Eleva, UroDiagnost Eleva, MultiDiagnost Eleva with Flat Detector, MultiDiagnost Eleva
28 March 2018
X Ray, Fluoroscopy Systems
Model: - 708032: MultiDiagnost Eleva - 708033: UroDiagnost Eleva - 708034: MultiDiagnost Eleva with Flat Detector - 708035: MultiDiagnost Eleva with Flat Detector - 708036: MultiDiagnost Eleva - 708037: MultiDiagnost Eleva with Flat Detector - 708038: MultiDiagnost Eleva w Flat Detector
MHRA reference: 2018/004/009/291/034
Ranfac
28 March 2018
Surgical instruments, minimal access
Model: Marrow CellutionTMPlease see attached excel sheet
MHRA reference: 2018/003/031/601/002
Scaffdex Ltd: RG000N RegJoint
14 March 2018
Dermal substitues, tissue scaffods
MHRA reference: 2018/003/022/601/006
Siemens: ADVIA Chemistry Urea Nitrogen
April 2018
IVDs, Clinical Chemistry
Model: ADVIA Chemistry Urea Nitrogen
MHRA reference: 2018/004/009/601/002
St. Jude Medical: Nanostim™ Leadless Pacemaker
05 April 2018
Implants, active, pacemakers
Model: S1DLCP
MHRA reference: 2018/004/006/291/012
Thermo Fisher Scientific
26 March 2018
IVDs, bacteriology
Model: CT1412B
MHRA reference: 2018/004/010/601/019
Thoratec Corporation: HeartMate 3™ Left Ventricular Assist System
April 5 2018
Implantable ventricular assist devices
Model: 106524INT HM3 LVAS Kit
MHRA reference: 2018/004/009/291/032
Immucor GTI Diagnostics, Inc: MATCH IT! DNA software
23 March 2018
IVD, genetic testing
MHRA reference: 2018/004/006/291/008