Field safety notices - 2 to 6 February 2015
List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 February 2015.
You can see copies of field safety notices in our filecamp folder.
Agfa HealthCare: Direct Radiography system DX-D 600
Device description: x-ray, digital acquisition systems
Model: DX-D 600
MHRA reference: 2015/001/019/701/002
Air Liquide: Mixt ventilator
28 January 2015
Device description: lung ventilators
Model: Mannal T50, Mannal T50DE, MonnalT50JP
MHRA reference: 2015/002/004/081/001
Aspen Medical Europe: bi-manual irrigating / aspirating handpieces
3 February 2015
Device description: phacoemulsification / vitrectomy systems
Model: Handpiece
MHRA reference: 2015/002/004/081/012
B Braun Medical: Celiste PICC-Cel
17 July 2014
Device description: vascular cannula and catheters
Model: CELSITE PICC-CEL 4F SINGLE LUMEN
MHRA reference: 2014/010/010/121/002
Baxter AG: Easy Spray, Tissomat
January 2015
Device description: surgical devices, non-powered
Model: 0600075, 1504275, 0600123, 0600032, Z9501100700201, Z9501100999901, Z9501100999999
MHRA reference: 2015/001/023/081/036
Baxter Healthcare SA: MiniCap with Povidone-Iodine
January 2015
Device description: dialysis, peritoneal
MHRA reference: 2015/001/030/131/007
Baxter Healthcare SA: syringe tip cap
January 2015
Device description: injection devices
MHRA reference: 2015/001/021/081/009
Boston Scientific: IntellaTip MiFi™ Open-Irrigated Ablation Catheter
4 February 2015
Device description: therapy tissue ablation
Model: M004EPM96200, M004EPM9620K20 and M004EPM9620N40
MHRA reference: 2015/002/005/181/004
Cantel Medical UK
26 January 2015
Device description: cssd wash/clean/drying equipment
MHRA reference: 2015/001/028/131/003
GE Healthcare
Device description: magnetic resonance, equipment and accessories
Model: GE MR Systems - refer to comments for product list
MHRA reference: 2015/002/004/081/018
Mackworth Healthcare Ltd
4 February 2015
Device description: hoists and slings
Model: Oak H/D Solid Med Clip 18610 Sling with DOSEC clips
MHRA reference: 2014/010/030/401/004
Medicina: infant feeding tube
20 January 2015
Device description: feeding systems and tubes
MHRA reference: 2014/003/028/081/009
Medtronic 3F Therapeutics: 3f Enable™ Aortic Bioprosthesis
January 2015
Device description: implants, non-active, cardiovascular heart valves
Model: 6000
MHRA reference: 2014/011/020/081/002
Philips Medical Systems: MultiDiagnost Eleva FD
January 2015
Device description: x-ray, fluoroscopy systems
Model: 6000
MHRA reference: 2014/011/020/081/002
Rehabilitation Manufacturing Services
2 February 2015
Device description: buggies for disabled people
Model: RMS Simba Size 2
MHRA reference: 2014/012/019/401/012
Siemens Healthcare Diagnostics Inc: ADVIA Centaur Systems Progesterone
January 2015
Device description: IVDs, clinical chemistry
MHRA reference: 2015/001/029/601/009
Smiths Medical International: CADD™ Medication Cassette Reservoir
2 February 2015
Device description: infusion systems
MHRA reference: 2015/001/029/071/001
The Laryngeal Mask Company: LMA® Supreme (New Cuff) Size 5
Device description: airway devices
Model: laryngeal mask airway
MHRA reference: 2015/001/030/181/010
W.L. Gore & Associates: GORE TIGRIS® Vascular Stent
29 January 2015
Device description: implants, non active, peripheral vascular stents
Model: PHB051002
MHRA reference: 2015/002/002/701/001