Field Safety Notice - 25 to 29 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 September 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 FSNs
Bio-Rad: MONOLISA™ HCV Ag-Ab ULTRA V2
24 March 2017
IVDs, viral microbiology
MHRA reference: 2017/009/025/291/007
Biomet: Various kits (see recall notice for details)
11 July 2016
Implants, reconstructive, body contouring
Model: Anticoagulant Citrate Dextrose Solution
MHRA reference: 2016/007/022/701/012
Carl Zeiss: INTRABEAM PRS 500
25 August 2017
Radiotherapy
MHRA reference: 2017/009/021/291/006
Christoph Miethke: proSA Tool Set
19 September 2017
Implants, non active, hydrocephalus shunt
Model: FV792T
MHRA reference: 2017/009/025/701/003
Elekta
September 2017
Radiotherapy planning and verification systems
Model: ERGO++ and ERGO Localizer
MHRA reference: 2017/009/022/701/017
Exactech: Tibial Tray, Offset; Offset Spine Stiffener Screw
19 September 2017
Joint prosthesis, knee
MHRA reference: 2017/009/021/701/005
HMT Medizintechnik: see attached lists
28 August 2017
Blood/fluid warming systems
Model: siehe angehängte Liste
MHRA reference: 2017/009/027/701/014
Integra: CUSA Clarity (Footswitch)
25 September 2017
Surgical, diathermy
Model: C7000 (footswitch only)
MHRA reference: 2017/009/027/701/012
MEDICREA: PASS OCT/ Pedicle screwdriver shaft A17210100
13 July 2017
Orthopaedic surgical instruments - Insertion/extraction tools
MHRA reference: 2017/009/020/291/003
Medtronic: Neuray® Neurosurgical Patties and Strips; Merocel® Neurosurgical Patties and Packing
September 2017
Basic dressings, absorbents, swabs, procedure packs
Model: Neuray: 8003097, 8003098, 8003099, 8004000, 8004001 , 8004002, 8004003, 8004004, 8004005, 8004006, 8004007, 8004008, 8004009, 8004050, 8004051, 8004052, 8004053, 8004054, 8004055, 8004056, 8004057 Merocel: 300501, 300503, 300505, 300506, 300507, 300509, 300510, 300514, 300515, 400611
MHRA reference: 2017/009/025/291/011
Molnlycke Health Care: See attached Product Table
22 September 2017
Surgical devices, non-powered
MHRA reference: 2017/009/022/291/024
Siemens
September 2017
IVDs, clinical chemistry
Model: Handheld Barcode reader
MHRA reference: 2017/009/022/601/009
TEC COM GmbH Gesellschaft für Technik, Technologie und Vermarktung
2 August 2017
Blood/Fluid warming systems
MHRA reference: 2017/009/025/291/006
W.L. Gore & Associates: Conformable GORE® TAG® Thoracic Endoprosthesis
September 2017
Implants, non active, endoprostheses for aortic aneurysms
Model: TGE212110
MHRA reference: 2017/009/025/291/009
Zimmer: Custom Rotating Hinged Knee
20 September 2017
Joint prosthesis, knee
MHRA reference: 2017/009/022/291/005