Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.

Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.

On April 23, 2021, Philips Healthcare issued an Urgent Medical Device Correction notice to customers via letter notifying them that Philips Healthcare has discovered through trend analysis an increase in the failure rate of certain low-voltage DC power supplies (DCPS) used in these products. Each system contains multiple DCPS, some of which may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering. HOW TO IDENTIFY AFFECTED PRODUCTS: For systems mentioned above, If 'Rev 8.2.16 or Rev 8.2.17 appears in the lower (black) area of the start-up screen, the system is affected. Philips will be notifying customers with affected systems. ACTION TO BE TAKEN BY CUSTOMER / USER: The likelihood of a system failure occurring is remote, and the users are recommended to follow their pre-established procedures for managing potential patient safety in the event that the system shuts down. ACTIONS PLANNED BY PHILIPS: Philips will replace the affected DCPS. This service will be provided free of charge for all affected systems. A Philips Healthcare service representative will contact customers with affected devices to arrange for the service. .