Incisive CT Plus -Whole-body computed tomography — Class II medical device recall Z-1625-2023
Ongoing recall by PHILIPS HEADQUARTERS CAMBRIDGE, reported 2023-05-31, distributed in AR, CA, OK, TX. Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis,
| Recall number | Z-1625-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS HEADQUARTERS CAMBRIDGE, Cambridge, MA, United States |
| Recall initiated | 2023-04-12 |
| Classified | 2023-05-23 |
| Reported by FDA | 2023-05-31 |
| Distributed | AR, CA, OK, TX |
| Countries outside the US | AR, AT, AU, CH, CN, CO, CZ, DE, ES, FR, GB, HK, IN, JP, KW, LT, LV, NL, NO, PT, RO, TH, TW, VN |
| Quantity | 5 units |
| UPC / GTIN / UDI-DI | 00884838103474 |
| Serial numbers | 530537, 554032, 554060, 554065, 554078 |
| Model numbers | 728149 |
Product
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Reason for recall
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
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-1625-2023. 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.