2008T Hemodialysis System CDX (2012-04-16)

Starting date:

April 16, 2012

Posting date:

October 14, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-41769

• Reason
• Affected products

Recalled Products

2008T Hemodialysis System CDX 

Reason

The correction of 10 machines at a customer site was required because they were installed with an unapproved version of software (v 2.30) preloaded on the function board. The version that was installed is approved in the United States but has not yet been reviewed and approved by Health Canada. The newest version is very similar to the currently approved version (v2.13) but does include a change to the user interface and as such requires a Class 3 amendment to the licence before sale in Canada. Due to the similarity between the two versions, the error was not immediately noticeable to the user or patients and thus not observed when the first machines were installed and put in use on Wednesday April 11, 2012.

Affected products