FDA Device recall Z-0238-2022
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
- FDA Device
- Class II
- ongoing
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) by Philips Healthcare, citing 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 capabilit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0238-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-24 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
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.
Identifiers
| code_info | Azurion 2.1(L1) and 2.1(L2) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0238-2022%22
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