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 issues |
| Product | BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454 |
| Quantity | 85 |
| Distribution | Worldwide Distribution - USA including the states of AR, CA, FL, GA, ID, LA, ME, MI, MN, MO, MS, NJ, NY, OH, OK, PA, and TX. Government Facilities: AR, FL, MN, OH, and OK. and the countries of: Canada, China, Denmark, Germany, Italy, South Korea, Spain, Sweden, Switzerland, Taiwan, and United Kingdom. |
| Initiated | 2014-11-04 |
| Classified | 2014-11-25 |
| Terminated | 2018-07-02 |
| Recall number | Z-0450-2015 |
| 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-0450-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69783/
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