Class II — Philips Medical Systems (Cleveland) Inc
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 . |
| 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 |
| Quantity | 32 |
| Distribution | Worldwide Distribution: US Distribution in states of: FL, NC, and VT; and the countries of Argentina, Austria, Belgium, Canada, Denmark, France, India, Italy, Japan, Netherlands, United Kingdom, and Vietnam. |
| Initiated | 2014-11-09 |
| Classified | 2014-11-26 |
| Terminated | 2015-09-14 |
| Recall number | Z-0473-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Medical Systems (Cleveland) Inc (Z-0473-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69793/
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