Veradius Unity Mobile Surgery C-arm — Class II medical device recall Z-0230-2024
Ongoing recall by Philips North America, reported 2023-11-15, distributed in GU, PR. Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that ha
| Recall number | Z-0230-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2023-10-04 |
| Classified | 2023-11-09 |
| Reported by FDA | 2023-11-15 |
| Distributed | GU, PR |
| Reason classes | labeling |
Product
Veradius Unity Mobile Surgery C-arm
Reason for recall
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
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-0230-2024. 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.