Pinnacle3 VCC P/N 4598 001 41341 REV A — Class II medical device recall Z-0206-2013
Terminated recall by Philips Medical Systems (Cleveland), Inc., reported 2012-11-14, distributed nationwide. Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1
| Recall number | Z-0206-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland), Inc., Fitchburg, WI, United States |
| Recall initiated | 2012-10-05 |
| Classified | 2012-11-05 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2013-02-21 |
| Distributed | Nationwide (US) |
| Quantity | 11 |
| Reason classes | software |
| Serial numbers | 317, 318, 319, 320, 321, 342, 343, 344, 345, 346, 347 |
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 modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.
Reason for recall
Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.