Incisive CT Computed Tomography X-ray System Model: 728143 — Class II medical device recall Z-1265-2021
Terminated recall by Philips North America Llc, reported 2021-03-24. Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuat
| Recall number | Z-1265-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2021-02-22 |
| Classified | 2021-03-16 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2023-02-09 |
| Countries outside the US | AU, BO, CN, DE, HU, ID, IT, JP, KR, LV, PH, RO, TH |
| UPC / GTIN / UDI-DI | 00884838059849, 00884838085015 |
| Serial numbers | 500048, 500225, 500226, 500227, 500229, 500230, 500231, 500233, 500241, 500244, 500245, 500246, 500247, 500248, 500254, 500256, 500257, 500258, 500260, 500261, 500263, 500264, 500265, 500269, 500270 and 80 more |
| Model numbers | 728143 |
Product
Incisive CT Computed Tomography X-ray System Model: 728143
Reason for recall
Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees
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-1265-2021. 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.