Ingenuity CT Model No — Class II medical device recall Z-2385-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-08-17, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance o
| Recall number | Z-2385-2016 |
|---|---|
| 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 | 2016-04-29 |
| Classified | 2016-08-10 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2018-07-02 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BO, BR, CH, CN, CO, DE, EE, ES, FI, FR, GB, ID, IE, IL, IN, IT, JO, JP, KR, LB, LT, LV, MY, NL, NO, NZ, PA, PH, PL, PT, SE, SK, TH, TR, TW, VN, ZA |
| Quantity | 205 units |
| Reason classes | software |
| Model numbers | 300003, 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020, 300021, 300022, 300024, 300025, 300027, 300028, 300029, 30003, 300030, 300031, 300032, 300033 and 186 more |
Product
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Reason for recall
Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
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-2385-2016. 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.