Class II — Philips Medical Systems, 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| Reason | The delivered application software was an outdated version to the model of equipment. |
| Product | Easy Diagnost Eleva Universal Fluoroscopic applications |
| Quantity | 19 devices |
| Distribution | Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC. |
| Initiated | 2013-10-30 |
| Classified | 2013-12-02 |
| Terminated | 2017-01-09 |
| Recall number | Z-0431-2014 |
| 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, Inc. (Z-0431-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66705/
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