Brilliance iCT — Class II medical device recall Z-0791-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-02-05, distributed in DC, IL, IN, MI, MO, NY, OH, OR…. The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs.
| Recall number | Z-0791-2014 |
|---|---|
| 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 | 2011-03-07 |
| Classified | 2014-01-29 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2014-04-28 |
| Distributed | DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, VT |
| Countries outside the US | AU, BE, CN, DE, IL, IN, IT, NL |
| Quantity | 23 |
| Serial numbers | 100019, 100023, 100087, 100103, 100170, 200005, 200013, 200047, 7006, 7060, 7154, 7298, 7349 |
| Model numbers | 728231, 728243, 728306, 728311, 728326 |
Product
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are 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. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Reason for recall
The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect.
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-0791-2014. 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.