Progeny Vantage Panoramic X-Ray System with Cephalometric (2013-09-27)

Starting date:

September 27, 2013

Posting date:

October 28, 2013

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-36391

• Reason
• Affected products

Recalled products

A. Progeny Vantage Panoramic X-Ray System with Cephalometric 

Reason

This field action is being initiated to correct a recently identified real time controller (RTC)firmware error found in firmware versions 3.0, 3.1, 3.2, and 3.3. This error may cause the column of the Vantage Panoramic X-Ray unit to continue moving vertically despite the release of the movement control button (i.e. "failure to stop"). If this occurs while a patient is positioned under the column, there is the potential for injury, such as bruising, sprains, or resulting from quick movements to avoid the moving column.

Affected products