ALLURA XPER UNIT(2015-09-22)

Starting date:

September 22, 2015

Posting date:

October 8, 2015

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-55302

• Reason
• Affected products

Affected Products

1. ALLURA XPER FD10/10 - MAIN UNIT
2. ALLURA XPER FD20/10 SYSTEM - MAIN UNIT
3. ALLURA XPER FD20/20
4. ALLURA XPER FD10
5. ALLURA XPER FD20 SYSTEM - MAIN UNIT
6. ALLURA XPER FD20 OR TABLE

Reason

Philips has become aware that memory problems on the Embedded Technology eXtended (ETX®)-module in the system interface board (SIB) box cause intermittent failures. The SIB box plays a role in starting and stopping and controlling the image functionality. Although highly intermittently, the failure can occur both during start up as well as during system use. The failure does not affect an active X-ray run and the run can be finished. However, no new run can be started until the system is rebooted. As such, the failure has no impact on the critical moment in a critical procedure.

Affected products