Allura Xper R8.2 and UNIQ R1.0 X-Ray Systems (diagnostic, fluoroscopic x-ray system) 의 리콜

Recall

RC-2016-RN-00881-1

Class I

2016-07-01

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00881-1

Philips healthcare has identified through trend analysis an increase in the failure rate of certain low-voltage dc power supplies (“dcps”) used in the affected 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. the likelihood of a system failure to occur is remote.The loss of key imaging functionality or mechanical movement during a diagnostic or therapeutic procedure may interrupt or require the abandonment of the procedure. in rare instances, unavailability of live imaging might lead to a possible injury to the patient when the system fails during a critical phase of the procedure.

Philips will replace the affected DCPS. Philips Healthcare service representative will contact customers with affected devices to arrange for the service. In the interim, the users are recommended to follow their pre-established procedures for managing potential patient safety in the event that the system shuts down.