Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The… — Class II medical device recall Z-0950-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-03-20, distributed in AR, AZ, IN, KS, LA, MA, MN, MS…. This field change order is being released to update software and customer release notes to the affected instal
| Recall number | Z-0950-2013 |
|---|---|
| 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 | 2013-02-15 |
| Classified | 2013-03-14 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2014-04-11 |
| Distributed | AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, OH, OR, PA, TN, TX, VT, WV, WY |
| Countries outside the US | AU, BE, CH, CN, DE, FR, IL, JP, NO |
| Quantity | 42 units |
| Reason classes | software |
| Serial numbers | 300003, 300004, 300005, 300010, 300011, 300012, 300014, 300015, 300018, 300027, 300041, 300053, 300059, 300066, 300070, 300071, 300073, 300074, 300078, 300079, 300080, 300082, 300084, 300086, 300091 and 17 more |
Product
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems 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
This field change order is being released to update software and customer release notes to the affected installed base.
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-0950-2013. 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.