Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 14, 2012
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 norm
Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems (Cleveland), Inc. recalled Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchb… - a moderate-severity action.
Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchb… was recalled by Philips Medical Systems (Cleveland), Inc. in November 14, 2012. Reason: Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3…. Check the official notice for the remedy. Verify recall #Z-0206-2013 with the FDA Devices before acting.
The recall
Philips Medical Systems (Cleveland), Inc. issued this moderate-severity FDA Devices recall-Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3….
- Moderate
- severity level
- 11 units
- affected scope
- Class II
- classification
- November 14, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0206-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0206-2013) was formally reported on November 14, 2012, with the manufacturer initiating the action on October 5, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Medical Systems (Cleveland), Inc. is listed as the recalling firm, operating out of Fitchburg, WI. Federal records list the affected scope as 11.
The documented reason for this recall is: Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution. Distribution data in the federal record shows the product reached: Nationwide distribution: USA including states of: ME, MI, NY, and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
11
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0206-2013 |
| Date reported | November 14, 2012 |
| Date initiated | October 5, 2012 |
| Recalling firm | Philips Medical Systems (Cleveland), Inc. |
| Firm location | Fitchburg, WI |
| Affected scope | 11 |
| Distribution | Nationwide distribution: USA including states of: ME, MI, NY, and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0206-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Philips Medical Systems (Cleveland), Inc.. Units affected: 11.
Why was this product recalled? ▼
Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2012. Severity: Moderate. Recall number: Z-0206-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution: USA including states of: ME, MI, NY, and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0206-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 14, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.