Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning… — Class II medical device recall Z-0674-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-01-23, distributed in IN, OH, OR. Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and thei
| Recall number | Z-0674-2013 |
|---|---|
| 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 | 2012-12-03 |
| Classified | 2013-01-15 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2013-06-18 |
| Distributed | IN, OH, OR |
| Countries outside the US | AU, BE, CN, IL, SE |
| Reason classes | software |
| Serial numbers | 300010, 300030 |
| Model numbers | 728231, 728326 |
Product
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Reason for recall
Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.
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-0674-2013. 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.