Philips Azurion Interventional Fluoroscopic X-ray System with… — Class II medical device recall Z-2534-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-08-14, distributed nationwide. Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
| Recall number | Z-2534-2024 |
|---|---|
| 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 | 2024-07-15 |
| Classified | 2024-08-08 |
| Reported by FDA | 2024-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, LB, LK, LT, LV, MA, MX, MY, NG, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 3,011 units |
| UPC / GTIN / UDI-DI | 00884838085251, 00884838085268, 00884838085275, 00884838085282, 00884838085350, 00884838085367 |
| Model numbers | 722063, 722064, 722067, 722068, 722078, 722079 |
Product
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedure. Model Numbers: 722063, 722064, 722067, 722068, 722078 and 722079
Reason for recall
Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
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-2534-2024. 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.