Philips CT systems are advanced continuous-rotation computed… — Class II medical device recall Z-1273-2021
Terminated recall by Philips Healthcare (Suzhou) Co., Ltd., reported 2021-03-24, distributed nationwide. Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result
| Recall number | Z-1273-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare (Suzhou) Co., Ltd., Suzhou, N/A, China |
| Recall initiated | 2021-02-24 |
| Classified | 2021-03-17 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2023-02-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BO, CN, DE, ES, HU, IT, JP, KR, LV, RO, RS, RU, SA, SE, TH |
| Quantity | 109 systems |
| UPC / GTIN / UDI-DI | 00884838059849, 00884838085015 |
Product
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.
Reason for recall
Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.
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-1273-2021. 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.