Brilliance CT — Class II medical device recall Z-0400-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-12-16, distributed in CA, NV. Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when p
| Recall number | Z-0400-2016 |
|---|---|
| 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 | 2006-04-25 |
| Classified | 2015-12-10 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2015-12-15 |
| Distributed | CA, NV |
| Quantity | 54 units |
| Reason classes | software |
| Model numbers | 728243 |
Product
Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
Reason for recall
Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.
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-0400-2016. 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.