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 | The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch. |
| Product | Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction. |
| Quantity | M/N: 728256, 4 units; M/N: 728246, 89 units; M/N: 728235, 9 units & M/N: 728231, 207 units |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, DE, FL, GA, IN, KY, MA, MD, MI, MN, MS, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, VT, WI & WV, and the countries of Australia, Austria, Bosnia & Herzegovina, Chile, China, Croatia, Denmark, Equatorial Guinea, France, Germany, Greenland, Iceland, Indonesia, Israel, Japan, Kazakhstan, Netherlands, Nigeria, Norwa… |
| Initiated | 2013-07-05 |
| Classified | 2013-09-16 |
| Terminated | 2015-09-15 |
| Recall number | Z-2210-2013 |
| 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-2210-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65691/
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