ALLURA XPER FD10/10, FD20/10, FD10, FD20 Main Units (2015-02-05)

Starting date:

February 5, 2015

Posting date:

March 5, 2015

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-52439

• 
  Reason
• 
  Affected products

Recalled Products

A. ALLURA XPER FD10/10 - Main Unit

B. ALLURA XPER FD20/10 System - Main Unit

C. ALLURA XPER FD10

D. ALLURA XPER FD20 System - Main Unit

Reason

Philips Healthcare has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with Health Canada safety code 20A and some provincial regulations. In certain circumstances, a software error can lead to a situation where the five minute Fluoroscopy Audible Signal does not sound, as required in Health Canada safety code 20A and some provincial regulations. No injuries attributed to the problem are reported.

Affected products