Ingenuity Core 128 — Class II medical device recall Z-1464-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-04-23, distributed nationwide. A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermitt
| Recall number | Z-1464-2014 |
|---|---|
| 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 | 2014-03-06 |
| Classified | 2014-04-16 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2014-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BD, BE, BG, BR, CH, CN, DE, ES, FR, GB, ID, IE, IN, JP, KR, NI, OM, RU, TH, TR |
| Quantity | 116 units |
| Reason classes | software |
| Serial numbers | 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029 and 82 more |
Product
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Reason for recall
A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
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-1464-2014. 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.