Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI....
FDA Device Recall #Z-0206-2013 — Class II — October 5, 2012
Recall Summary
| Recall Number | Z-0206-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 5, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems (Cleveland), Inc. |
| Location | Fitchburg, WI |
| Product Type | Devices |
| Quantity | 11 |
Product Description
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.
Distribution Pattern
Nationwide distribution: USA including states of: ME, MI, NY, and WI.
Lot / Code Information
Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347
Other Recalls from Philips Medical Systems (Cleveland), ...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1312-2014 | Class II | Pinnacle3 Radiation Therapy Planning (RTP) Syst... | Feb 11, 2014 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.