Computed Tomography X-Ray System Brilliance Workspace Portal — Class II medical device recall Z-0675-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-01-23, distributed in AZ, CA, CO, IL, IN, MA, ME, MI…. Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with s
| Recall number | Z-0675-2013 |
|---|---|
| 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 | 2012-09-11 |
| Classified | 2013-01-15 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2014-02-14 |
| Distributed | AZ, CA, CO, IL, IN, MA, ME, MI, MO, NC, NJ, NY, OR, TN, TX, VA, WI |
| Countries outside the US | AT, CA, CH, CN, ES, FR, GB, IE, IN, IT, JP, NL, NO, TH |
| Quantity | 108 units |
| Reason classes | labeling, software |
| Serial numbers | 79906, 79921, 79927, 79937, 80007, 80026, 80031, 80040, 80058, 80062, 80066, 80069, 80087, 80110, 80121, 80155, 80167, 80168, 80169, 80174, 80192, 80193, 80195, 80201, 80208 and 83 more |
| Model numbers | 728269 |
Product
Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The portal (together with the scanner) provides image processing and display through software applications that process, analyze, display, quantify and interpret medical images/data.
Reason for recall
Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the center line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu.
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-0675-2013. 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.