The Brilliance 64 and Ingenuity CT are whole body Computed Tomography… — Class II medical device recall Z-2223-2012
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2012-08-29, distributed in IN, OH. 1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the d
| Recall number | Z-2223-2012 |
|---|---|
| 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 | 2012-07-18 |
| Classified | 2012-08-17 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2013-02-22 |
| Distributed | IN, OH |
| Countries outside the US | AU, BE, CN, IL, SE |
| Quantity | 8 |
| Reason classes | software |
| Serial numbers | 300010, 300018, 300030, 91003, 95130, 95157, 95504, 9654 |
Product
The Brilliance 64 and Ingenuity CT are whole body 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Reason for recall
1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable Dose Check after ente
Machine access
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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.