Computed Tomography X-ray Systems Brilliance CT 64-channel with… — Class II medical device recall Z-2254-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-08-05, distributed nationwide. 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some i
| Recall number | Z-2254-2015 |
|---|---|
| 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 | 2015-02-05 |
| Classified | 2015-07-24 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2018-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CA, CH, CN, CO, DE, DK, ES, FI, FR, GB, HK, ID, IE, IN, IQ, IR, IT, JP, KR, LT, LV, MX, MY, NL, NO, NZ, PA, PH, RU, SE, SG, SK, TH, TN, TR, TW, VN, ZA |
| Quantity | 4 units |
| Serial numbers | 95130, 95157, 95504, 9654 |
| Model numbers | 728231 |
Product
Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. 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
5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
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-2254-2015. 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.