FDA recall Z-0835-2024

Product

Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 - 722078, 722223; Azurion 7M20 - 722079, 722224; Azurion 3 M15 (China) - 722280;

Reason for recall

System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-12-12

Report date

2024-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0835-2024