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 | Flat Panel Display (FPD) failed to remain securely locked in the deployed position. |
| Product | BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging. |
| Quantity | 407 |
| Distribution | Worldwide Distribution - USA including the states of : AZ, CA, CO, DC, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY,OH, OK, OR, PA, TX, VT, WA,WI. Government Facilities: AZ, CA, CO, FL, HI, IA, KY, MA, MN, MO, NC, ND, NE, NV, OH, OK, SD, TX, and WV. and the countries of : Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Ger… |
| Initiated | 2014-06-23 |
| Classified | 2014-07-02 |
| Terminated | 2015-09-24 |
| Recall number | Z-1982-2014 |
| 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 (Cleveland) Inc (Z-1982-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68644/
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