Brilliance iCT SP — Class II medical device recall Z-0402-2018
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-01-31, distributed nationwide. Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisitio
| Recall number | Z-0402-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2017-07-11 |
| Classified | 2018-01-23 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2019-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 559 total |
| Reason classes | device malfunction, software |
| Model numbers | 200003, 200009, 200011, 200013, 200015, 200017, 200018, 200019, 200022, 200023, 200024, 200027, 200030, 200032, 200038, 200040, 200041, 200043, 200044, 200047, 200049, 200051, 200052, 200061, 200063 and 43 more |
Product
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Reason for recall
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
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-0402-2018. 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.