Allura Xper Products (2016-04-05)

Starting date:

April 5, 2016

Posting date:

April 22, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-58040

• 
  Reason
• 
  Affected products

Affected products

A. ALLURA XPER FD10

B. ALLURA XPER FD20 (PRODUCT OF ALLURACLARITY FAMILY)

C. ALLURA XPER FD20/20 (PRODUCT OF ALLURACLARITY FAMILY)

Reason

Philips has discovered through customer feedback and internal testing the following issues: 1. A failure with the image disk may cause the entire image processing chain to be blocked due to a SW design error. This causes image data to be lost, and eventually loss of live imaging functionality. 2. A filament error that may occur during the execution of an XperCT. When the filament error occurs, the run is aborted. After abort, new X-ray runs can be started immediately without system restart.

Affected products