Ingenuity Core 728321 Computed Tomography X-ray systems intended to… — Class II medical device recall Z-0695-2017
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-12-14, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Software error due to the filament on timer
| Recall number | Z-0695-2017 |
|---|---|
| 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 | 2016-11-12 |
| Classified | 2016-12-02 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2019-06-18 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DO, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, LB, LT, LV, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, QA, SE, SG, SK, TH, TN, TR, TW, VN, ZA |
| Quantity | 337 |
| Reason classes | software |
Product
Ingenuity Core 728321 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 for recall
Software error due to the filament on timer
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-0695-2017. 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.