Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray… — Class II medical device recall Z-1745-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-07-02, distributed nationwide. During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio frequency emiss
| Recall number | Z-1745-2014 |
|---|---|
| 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 | 2013-12-19 |
| Classified | 2014-06-21 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2015-08-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BE, BR, CA, CH, CN, CZ, DE, DK, DZ, EC, ES, FR, GB, ID, IL, IN, IT, JO, KR, LT, LU, MA, MX, MY, NL, NZ, OM, PH, PT, RU, SA, SE, SG, SI, SK, TH, UA, ZA |
| Quantity | 454 units |
| Serial numbers | 7185, 7187-7189, 7190, 7191-7199, 7200, 7201, 7243, 7244, 7245-7251, 7252, 7253-7267, 7268, 7269, 7270, 7271, 7272-7297, 7299, 7300, 7301, 7302, 7304-7317, 7318, 7319-7374, 7375, 7376-7379 and 94 more |
| Model numbers | 728243, 728244 |
Product
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
Reason for recall
During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio frequency emissions. Specifically, at the 48MHZ frequency, the testing indicated the Brilliance CT Big Bore was 3.5dB uV/meter higher than the applicable IEC 60601-1-2 standard specification.
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-1745-2014. 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.