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Philips Healthcare Recall 89020

Description: Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

Philips Healthcare Recall 89020 Information

StatusOngoing
Mandated?FDA Mandated
Recall NumberZ-0238-2022
Event ID89020
Event DescriptionPhilips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Product TypeDevices
DistributionUS Nationwide distribution
Quantity226 units
Recall Reason3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.
Device Classification20211201
Device Code InfoAzurion 2.1(L1) and 2.1(L2)
Center Classification Date20211124
Recall Initiation Date20210924
Recalling FirmPhilips Healthcare
Initial Notification Letter
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