Brilliance iCT Computed Tomography X-ray system — Class II medical device recall Z-0545-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-12-30, distributed nationwide. Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Cus
| Recall number | Z-0545-2016 |
|---|---|
| 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 | 2015-10-29 |
| Classified | 2015-12-24 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2018-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BR, CA, CH, CN, DE, EG, ES, FR, GB, ID, IE, IL, IN, IR, IT, JP, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PH, PL, PT, RU, SA, SE, SG, SK, TH, TN, TR, VN |
| Quantity | 51 units |
| Reason classes | software |
| Model numbers | 728306 |
Product
Brilliance iCT Computed Tomography X-ray system
Reason for recall
Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
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-0545-2016. 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.