Z-0206-2013Class II

Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3...

Name: Z-0206-2013 Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3...
Creator: Philips Medical Systems (Cleveland), Inc.
Published: 2012-10-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-10-05 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland), Inc. began a recall of Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer... on 2012-10-05. FDA classified it as Class II and gives the reason as "Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0206-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-05
Posted: 2012-11-05
Terminated: 2013-02-21
Recalling firm: Philips North America LLC
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Philips Healthcare, sent a "Customer Information Letter" dated 2012 Oct 05. The letter listed the affected products, problem description, how to identify affected products, advise on actions by customer / user, actions planned by Philips and further information and support. The letter stated that no action is needed on the part of the customer. The field service engineer will be scheduling a site visit to complete the replacement. Philips Healthcare will be delivering the correct VCC kit. For customers in North America if you need any further information or support concerning this issue, please contact our Customer Care Solutions Center at 1-800-722-9377. Select option 5 for "All Imaging Systems". Enter your site ID # (If you do not have a site ID#, simply pause for a moment.). Select option 5 for "Nuclear Medicine" and finally select option 3 for "Pinnacle" support.
Quantity in commerce: 11
Distribution: Nationwide distribution: USA including states of: ME, MI, NY, and WI.
Product codes and lots: Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0206-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0206-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-05

Product code IYE

K041577Class IIPinnacle3 Radiation Therapy Planning SystemAdac Laboratories / cleared 2004-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)