Stellant with Certegra Workstation - Stellant CT (2014-06-12)

Starting date:

June 12, 2014

Posting date:

July 3, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-40221

• Reason
• Affected products

Recalled Products

Stellant with Certegra Workstation - Stellant CT 

Reason

A customer complaint was received indicating that the contrast phase of a P3T (personalize patient protocol technology) generated diagnostic protocol was skipped. During an analysis of the issue, it was found that the protocol generated via p3t was not achievable by the Stellant with Certegra work station injector. The system informed the user via pop-up message "insufficient volume for programmed rate".  The protocol on the injector head would then revert to the previous injection protocol, but the display would continue to reflect the unachievable protocol to the technician. This could lead to a patient being injected with a different protocol than the technician intended. This situation only arises in Stellant systems with Certegra work stations with software version 100.60 or newer that have P3T software enabled.

Affected products