Brilliance iCT Computed Tomography X-Ray System — Class II medical device recall Z-0335-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-11-27, distributed nationwide. If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of
| Recall number | Z-0335-2014 |
|---|---|
| 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 | 2013-10-11 |
| Classified | 2013-11-15 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2015-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, IL, NL |
| Quantity | 9 units |
| Serial numbers | 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024, 100025 |
| Model numbers | 728306 |
Product
Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System 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
If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.
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-0335-2014. 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.