Dialysis, haemofilters: haemofiltration machine - Edwards Lifesciences Ltd - Aquarius systems GEF08200, GEF09500, GEF09600 and GEF09700 - updated

Device type: Dialysis, haemofilters: haemofiltration machine

Manufacturer: Edwards Lifesciences Ltd

Device name: Aquarius systems GEF08200, GEF09500, GEF09600 and GEF09700

Manufacturer's reference number: 2009-2-17

MHRA reference number: 2009/004/006/291/009

Summary: Software to be upgraded. Advice has been given by the manufacturer regarding the use of the device.

MHRA advice:

MDA/2011/095 - Medical Device Alert: Aquarius haemofiltration machine using software version 6.0 manufactured by Nikkiso Europe (previously Edwards Lifesciences Ltd)

This Alert provides an update on actions advised in MDA/2009/076.

Note:   We place field safety notices on our website for information. They will not normally require further action unless you have been contacted directly by the manufacturer or we have issued supplementary advice.