Brilliance CT Big Bore Oncology — Class II medical device recall Z-0013-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-10-23, distributed nationwide. There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols usin
| Recall number | Z-0013-2014 |
|---|---|
| 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 | 2013-08-30 |
| Classified | 2013-10-17 |
| Reported by FDA | 2013-10-23 |
| Terminated | 2014-05-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BE, BR, CH, CL, CN, DE, DK, EG, ES, FR, GB, HN, ID, IN, IT, KR, LB, LV, MX, NL, NO, PH, PL, RU, SA, SE, TH, TR, TW, UA, VN, ZA |
| Quantity | 258 |
| Serial numbers | 30075, 3079, 3090, 3127, 3410, 3478, 3500, 3679, 3721, 40013, 50026, 50043, 50177, 50181, 50182, 50189, 50195, 50198, 50200, 5067, 5072, 5073, 5143, 5317, 5439 and 233 more |
Product
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Reason for recall
There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.
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-0013-2014. 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.