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


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

Published 6 February 2015