The Brilliance CT 16 System Product Usage: The Brilliance 16 is a… — Class III medical device recall Z-2404-2012
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2012-09-26, distributed nationwide. Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to
| Recall number | Z-2404-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2012-08-28 |
| Classified | 2012-09-18 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BR, CN, DZ, IN, OM, SA |
| Quantity | 93 units |
| Reason classes | software |
| Serial numbers | 6436, 6437, 6438, 6439, 6440, 6441, 6442, 6443, 6444, 6445, 6447, 6448, 6449, 6450, 6451, 6452, 6453, 6454, 6455, 6456, 6457, 6458, 6459, 6460, 6461 and 68 more |
Product
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Reason for recall
Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.
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-2404-2012. 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.