FDA Device recall Z-2711-2014
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional…
- FDA Device
- Class II
- terminated
- Published 2014-10-08
On 2014-10-08 the FDA classified a Class II recall of The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional… by Philips Medical Systems Cleveland, citing ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2711-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-11 |
| Published | 2014-10-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AZ, CA, CT, FL, GA, MA, MS, OH, PA, TX, WY |
Product
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Reason
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
Identifiers
| code_info | Ingenuity CT: 728326 300005,300010,300012,300016,300017,300019,300020,300021,300028,300029, 300031,300032,300033,300…Ingenuity CT: 728326 300005,300010,300012,300016,300017,300019,300020,300021,300028,300029, 300031,300032,300033,300035,300037,300039,300043,300047,300050,300051, 300052,300054,300055,300057,300060,300061,300062,300063,300072,300074, 300082,300086,300087,300089,300094,300095,300100,300101,300102,300106, 300108,300110,300112,300113,300129,300135,300136,300140,300143 Ingenuity Core: 728321 310001,310002,310009,310055,310059,310064,310069,310070,310087,333015 Ingenuity Core128: 728323 300137,320003,320005,320006,320018,320024,320029,320030,320033,320037, 320078,320092,320099,320103,320114,336011,336012,336013,336016,336018 |
|---|
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-2711-2014%22
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