The device is a whole-body CT x-ray system — Class II medical device recall Z-0576-2024
Completed recall by Philips North America Llc, reported 2023-12-27, distributed in AL, AR, AZ, CA, FL, GA, HI, IL…. Three software issues affecting incorrect image display, error interpreting patient images due to image report
| Recall number | Z-0576-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2022-03-29 |
| Classified | 2023-12-18 |
| Reported by FDA | 2023-12-27 |
| Distributed | AL, AR, AZ, CA, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MS, NC, NJ, NM, NY, OH, OK, PA, RI, TN, TX |
| Countries outside the US | AR, AT, AU, BO, CA, CH, CL, CO, CR, CZ, DE, EC, EG, ES, FR, GB, GR, HK, HU, IL, IN, IT, JP, KE, LB, LV, MA, NL, PA, PE, PL, PT, PY, RO, SE, TH, TR, TW, VN, ZA |
| Quantity | 330 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838085015, 00884838105508 |
| Serial numbers | 33002, 33010, 33012, 33018, 33019, 33020, 33021, 33023, 33025, 33029, 33030, 33031, 33033, 33034, 33037, 33038, 33040, 33041, 33042, 33045, 33046, 34001, 34002, 34003, 34004 and 305 more |
Product
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
Reason for recall
Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
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-0576-2024. 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.