Field safety notices - 8 to 12 June 2015
List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 June 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.
Latest FSNs
Barco
28 May 2015
Endoscopes, televisual systems
MHRA reference:
Biomet Orthopaedics: A.L.P.S. cortical locking screw 3.5mm x 60mm
9 June 2015
Osteosynthesis, bone screws
MHRA reference:
Fresenius Medical Care: KGaA: FX CorDiax 40, 50, 120 and FX CorDiax HDF600
2 June 2015
Dialysis, haemodialysis
Model: F00001588, F00001589, F00001590, F00001591, F00001592, F00002384, F00005649, F00005650, F00005651, F00005652, F00001593, F00001594, F00001595
MHRA reference:
Gainsborough Bathrooms: Gainsborough Bath
June 2015
Bath and aids
Model: Kent
MHRA reference:
GE Medical Systems: Innova, Optima and Discovery interventional system
9 June 2015
X ray, fluoroscopy systems
MHRA reference:
Philips Medical Systems: Q-Station
11 May 2015
Picture archiving and communication system (PACS)
MHRA reference:
RaySearch Laboratories
29 May 2015
Radiotherapy planning and verification
Model: RayStation
MHRA reference:
Roche Diabetes Care
SB_RDC_2015_04
Infusion systems
Model: Accu-Chek庐 Insight
MHRA reference:
Roche Diagnostics
3 June 2015
IVDs, clinical chemistry
Model: various models
MHRA reference:
Smith & Nephew Orthopaedics: Birmingham Hip鈩� Resurfacing (BHR) system
3 June 2015
Joint prosthesis, hip
MHRA reference:
Stryker: X3 Triathlon Insert CR#2 9MM
29 May 2015
Joint prosthesis, knee
Model: 5530G209
MHRA reference:
Unisurge International Limited: Unisurge oral swab applicators
5 June 2015
Basic dressings, absorbents, swabs, procedure packs
Model: F824330
MHRA reference: