Ingenuity CT Computed Tomography X-ray system — Class III medical device recall Z-0595-2017
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-11-23, distributed in AL, AZ, CO, GA, IN, KY, LA, MA…. The product label does not include the correct current rating.
| Recall number | Z-0595-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2016-10-13 |
| Classified | 2016-11-16 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2018-06-29 |
| Distributed | AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TN, TX, UT |
| Countries outside the US | AE, AR, AU, BE, CH, CN, DE, EG, ES, FR, GB, HK, IE, IL, IN, IT, JP, KR, LB, NL, NO, NZ, SE, TR, TW |
| Quantity | 27 |
| Reason classes | labeling |
| Model numbers | 728326 |
Product
Ingenuity CT Computed Tomography X-ray system, Model 728326
Reason for recall
The product label does not include the correct current rating.
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-0595-2017. 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.