Computed Tomography X-Ray System — Class II medical device recall Z-0479-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-01-02, distributed nationwide. Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software versi
| Recall number | Z-0479-2013 |
|---|---|
| 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 | 2012-09-28 |
| Classified | 2012-12-21 |
| Reported by FDA | 2013-01-02 |
| Terminated | 2013-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CN, DE, DZ, EC, FI, FR, GB, HK, IN, IT, KR, LB, RU |
| Quantity | 265 units |
| Reason classes | software |
| Serial numbers | 12876, 13924, 13994, 13996, 14104, 14116, 14677, 14682, 14694, 14695, 14702, 14707, 14710, 14727, 14728, 14730, 14824, 14840, 14926, 14930, 14932, 14940, 15008, 15015, 15017 and 248 more |
| Model numbers | 728260 |
Product
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) 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.
Reason for recall
Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW.
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-0479-2013. 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.