Incisive CT — Class II medical device recall Z-1871-2024
Ongoing recall by Philips North America Llc, reported 2024-05-29, distributed nationwide. Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, m
| Recall number | Z-1871-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2024-04-15 |
| Classified | 2024-05-20 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 18 units |
| UPC / GTIN / UDI-DI | 00884838085015 |
| Model numbers | 728143 |
Product
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
Reason for recall
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
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-1871-2024. 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.