Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray… — Class II medical device recall Z-2204-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-07-29, distributed in AR, AZ, CA, CO, CT, FL, GA, IA…. A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128,
| Recall number | Z-2204-2015 |
|---|---|
| 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 | 2015-03-17 |
| Classified | 2015-07-22 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2018-06-26 |
| Distributed | AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV, WY |
| Countries outside the US | AE, AR, AU, BD, BE, BG, BR, CH, CN, CO, DE, DK, EC, ES, FR, GB, ID, IL, IN, JP, KR, LV, NO, OM, PL, SA, SE, TH, TR, VN, ZA |
| Quantity | 55 units |
| Serial numbers | 300068, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320021, 320022, 320023, 320024, 320025, 320026, 320027, 320028 and 30 more |
Product
Head Holder shipped with Ingenuity Core 128 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.
Reason for recall
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system.
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-2204-2015. 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.