Brilliance Big Bore — Class II medical device recall Z-0177-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-11-04, distributed nationwide. The firm discovered Ring/Dot artifact due to X-ray measurement error.
| Recall number | Z-0177-2016 |
|---|---|
| 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 | 2015-09-14 |
| Classified | 2015-10-27 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2018-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BR, CA, CH, CN, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, HK, ID, IN, IQ, IR, IT, JO, JP, KR, LB, LT, LV, MX, MY, NG, NL, NO, OM, PA, PH, PL, PT, RO, RU, SA, SE, SG, TH, TN, TR, TW, UA, VN |
| Quantity | 268 units |
| Model numbers | 728243, 728244 |
Product
Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Reason for recall
The firm discovered Ring/Dot artifact due to X-ray measurement error.
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-0177-2016. 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.