Philips Azurion system — Class II medical device recall Z-1113-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2026-01-28, distributed in AR, AZ, IL, IN, MA, MO. Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-
| Recall number | Z-1113-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands |
| Recall initiated | 2025-12-12 |
| Classified | 2026-01-16 |
| Reported by FDA | 2026-01-28 |
| Distributed | AR, AZ, IL, IN, MA, MO |
| Quantity | 228 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838099203, 00884838099210, 00884838099227, 00884838099234, 00884838099241, 00884838099258, 00884838099265, 00884838099272, 00884838116726, 00884838116733, 00884838116740, 00884838116757, 00884838116764, 00884838116771, 00884838116788, 00884838116801 |
| Serial numbers | 100, 101, 1017, 103, 104, 105, 110, 111, 113, 115, 117, 118, 119, 123, 125, 128, 130, 131, 132, 135, 137, 138, 139, 156, 161 and 127 more |
| Model numbers | 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722229, 722230, 722231, 722232, 722233, 722234, 722235, 722236 |
Product
Philips Azurion system; Software Version Number: R3.1;
Reason for recall
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
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-1113-2026. 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.