Philips Azurion systems with software releases 2 — Class II medical device recall Z-0238-2022
Ongoing recall by Philips Healthcare, reported 2021-12-01, distributed nationwide. 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product exten
| Recall number | Z-0238-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Healthcare, Andover, MA, United States |
| Recall initiated | 2021-09-24 |
| Classified | 2021-11-24 |
| Reported by FDA | 2021-12-01 |
| Distributed | Nationwide (US) |
| Quantity | 226 units |
| Reason classes | software |
Product
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0238-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.