PHILIPS Incisive Computed tomography X-ray system Incisive CT… — Class II medical device recall Z-1507-2024
Ongoing recall by Philips North America, reported 2024-04-17, distributed nationwide. Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander stayi
| Recall number | Z-1507-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2020-12-24 |
| Classified | 2024-04-09 |
| Reported by FDA | 2024-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BG, BO, BR, CH, CN, CZ, DE, DK, EC, EG, ES, FR, GB, GR, HU, ID, IN, IQ, IT, JO, JP, KE, KR, KW, LB, LV, MY, NL, NO, NP, PE, PH, PK, PL, QA, RO, RS, SA, SE, TH, TN, TR, VN |
| Quantity | 428 units |
| UPC / GTIN / UDI-DI | 00884838085015 |
| Serial numbers | 33001, 33002, 33003, 500001, 500002, 500003, 500004, 500005, 500006, 500007, 500010, 500011, 500012, 500013, 500014, 500017, 500018, 500019, 500020, 500021, 500022, 500023, 500024, 500025, 500026 and 403 more |
| Model numbers | 728143 |
Product
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143
Reason for recall
Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
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-1507-2024. 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.