Company: Philips North America Llc
Date of Enforcement Report: 11/17/2021
Class II
PRODUCT
Philips Azurion Interventional Fluoroscopic X-Ray System
- Software version: 2.1.x
- Model numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
Recall Number: Z-0213-2022
REASON
When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.
RECALLING FIRM/MANUFACTURER
Philips North America Llc on 9/24/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
428 (US); 581 (OUS)
DISTRIBUTION
U.S. Nationwide and International