FDA recall Z-0471-2022

Philips North America Llc · Class II · device

Product

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

Reason for recall

(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

Distribution

Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom.

Key facts

Status: Terminated
Initiation date: 2021-11-12
Report date: 2022-01-19
Termination date: 2024-02-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0471-2022