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 | Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution. |
| Product | Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning mod… |
| Quantity | 11 |
| Distribution | Nationwide distribution: USA including states of: ME, MI, NY, and WI. |
| Initiated | 2012-10-05 |
| Classified | 2012-11-05 |
| Terminated | 2013-02-21 |
| Recall number | Z-0206-2013 |
| 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-0206-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63430/
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