Class II — Philips Medical Systems (Cleveland) Inc
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | A total of nine (9) units were distributed (3 units in the U.S & 6 units overseas) |
| Distribution | Worldwide distribution: USA including IN, OH and OR; and the countries: Australia, Belgium, China, Israel, and Sweden. |
| Initiated | 2012-12-03 |
| Classified | 2013-01-15 |
| Terminated | 2013-06-18 |
| Recall number | Z-0674-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Medical Systems (Cleveland) Inc (Z-0674-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63817/
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