FDAJuly 16, 2019device
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion series (within the l...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.
What to do
FDA enforcement status: Terminated
Brands named
philips north americaphilipsphilips north
Recall history
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