FDA-Device2022-01-19Class II
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
Philips North America Llc
Hazard
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available
Sold states
Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom.
Affected count
10 units (1 US and 9 OUS)
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0471-2022Don't want to check this manually?
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