Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The

FDA device recall Z-0716-2018 · posted 2018-02-24 · Terminated

Recall details

Recalling firm: Philips Electronics North America Corporation
Reason for recall: There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products. Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may also generate a peculiar burning smell that may be noticed. In some instances this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality is reduced.
Action taken: Customer Notification letter dated August 2017 were sent to affected customers. The letter identified affected product, problem and actions to be taken. The customer is requested to place this Field Safety Notice with the documentation of the system until this correction has been implemented. For questions contact your local Philips representative.
Root cause: Device Design
Status: Terminated
Product code: OWB
Quantity affected: 705
Distribution: Worldwide Distribution - US Nationwide; foreign distribution to Brazil, Germany, Iceland, Japan, Mexico, and (updated 6/25/18) Saudi Arabia.
Date initiated: 2018-01-04
Date posted: 2018-02-24
Date terminated: 2019-10-09
Location: Andover, MA

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES (K141979)	Philips Medical Systems Netherland BV	2014-08-19
ALLURA XPER FD; OR TABLE (K133292)	Philips Medical Systems Nederland B.V.	2014-03-05