The Ingenuity CT — Class II medical device recall Z-2711-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-10-08, distributed in AZ, CA, CT, FL, GA, MA, MS, OH…. Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was take
| Recall number | Z-2711-2014 |
|---|---|
| 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 | 2014-09-11 |
| Classified | 2014-09-29 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2018-06-26 |
| Distributed | AZ, CA, CT, FL, GA, MA, MS, OH, PA, TX, WY |
| Countries outside the US | AU, CH, DE, DK, FI, FR, GB, IE, IN, JP, KR, MY, NL, NO, NZ, RU, SE, SK, ZA |
| Quantity | 79 |
| Reason classes | labeling |
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 for recall
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
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-2711-2014. 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.