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Recall Observatory FDA recall evidence

Device product

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

Z-0238-2022

September 24, 2021

Class II

Product summary

Firm
Philips Healthcare
Event
Event 89020
Status
Ongoing
Classification
Class II
Quantity
226 units
Official record key
device-enforcement:Z-0238-2022

Official wording

Reason: 3D-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.

Code information: Azurion 2.1(L1) and 2.1(L2)

Distribution pattern: US Nationwide distribution

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software product that can