The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems… — Class II medical device recall Z-1791-2012
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2012-06-20, distributed in AL, CA, DC, DE, FL, GA, IA, IN…. Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently runnin
| Recall number | Z-1791-2012 |
|---|---|
| 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 | 2012-05-07 |
| Classified | 2012-06-08 |
| Reported by FDA | 2012-06-20 |
| Terminated | 2013-07-25 |
| Distributed | AL, CA, DC, DE, FL, GA, IA, IN, MA, MD, MN, MS, NC, NY, OH, OR, PA, TN, TX, VT, WA, WV |
| Countries outside the US | AR, AU, BE, BR, CA, CH, CN, CZ, DE, DK, EG, ES, FR, GB, GR, HU, ID, IL, IN, IS, IT, JO, JP, KR, LB, NL, NZ, PH, PL, PT, QA, RU, SE, SG, TH, TR, TW |
| Quantity | 241 |
| Reason classes | software |
| Model numbers | 728306, 728311 |
Product
The Brilliance iCT and iCT SP 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. The Brilliance iCT and iCT SP are used 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
Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards. The nonconformance documented below had the highest sc
Machine access
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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.