Ingenuity Core — Class II medical device recall Z-1771-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-06-17, distributed nationwide. The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomograp
| Recall number | Z-1771-2015 |
|---|---|
| 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 | 2015-03-06 |
| Classified | 2015-06-11 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2017-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BO, BR, CH, CN, CO, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, HR, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, KY, LB, LK, LT, LU, LV, MA, MT, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SG, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 215 units |
| Reason classes | packaging, device malfunction |
| Serial numbers | 310001, 310002, 310003, 310004, 310005, 310006, 310007, 310009, 310010, 310011, 310012, 310013, 310014, 310015, 310016, 310017, 310018, 310019, 310020, 310021, 310022, 310024, 310025, 310026, 310027 and 190 more |
| Model numbers | 728321 |
Product
Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Reason for recall
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
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-1771-2015. 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.