IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal… — Class II medical device recall Z-0473-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-12-03, distributed in FL, NC, VT. Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and a
| Recall number | Z-0473-2015 |
|---|---|
| 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 | 2014-11-09 |
| Classified | 2014-11-26 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2015-09-14 |
| Distributed | FL, NC, VT |
| Countries outside the US | AR, AT, BE, CA, DK, FR, GB, IN, IT, JP, NL, VN |
| Quantity | 32 |
| Reason classes | software |
| Model numbers | 881001, 881011, 881012, 881030 |
Product
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed
Reason for recall
Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (THV) to be implanted .
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-0473-2015. 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.