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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63430

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 05, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems (Cleveland), Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0206-2013
Recall number
Z-0206-2013
Initiated
October 05, 2012
Classification
Class II
Status
Terminated
Quantity
11

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

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.

Code information

Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347

Distribution pattern

Nationwide distribution: USA including states of: ME, MI, NY, and WI.