FDA Device recall Z-2664-2014
The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer…
- FDA Device
- Class II
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class II recall of The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer… by Philips Medical Systems Cleveland, citing during a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2664-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-09-01 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | OH |
Product
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
During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. Philips has disabled this feature at all sites evaluating 4.0 Beta 2 software. Philips will issue a software up
Identifiers
| code_info | 91003, 30018, 95504, 300004, 300030, 300010, 95130, 95157 |
|---|
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-2664-2014%22
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