FDA Device recall Z-0950-2013
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray S…
- FDA Device
- Class II
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class II recall of Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray S… by Philips Medical Systems Cleveland, citing this field change order is being released to update software and customer release notes to the affected installed base.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0950-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-15 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, OH, OR, PA, TN, TX, VT, WV, WY |
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
This field change order is being released to update software and customer release notes to the affected installed base.
Identifiers
| code_info | Brilliance 64: 728231 & Ingenuity CT: 728326, 728323. System Code # 728231, Serial #: 9654, 91003, 95130, 95157, 955…Brilliance 64: 728231 & Ingenuity CT: 728326, 728323. System Code # 728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code # 728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300014,300015,300018,300027,300041,300053,300059,300066,300070,300071,300073,300074,300078,300079,300080,300082,300084,300086,300091,300095,300101,300102,300112,300127,300128,300129,300131,300132,310064 System Code # 728323, Serial #: 320033 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0950-2013%22
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