Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, Manufactured and Distributed by: Varian Medical Systems Inc., Palo Alto, CA. For use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.
FDA Recall Z-2200-2011 · Posted 2011-05-16
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Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-03-30
Date Terminated2012-06-19
Product Quantity598 units
Reason for Recall
A software anomaly has been identified with the Optical Guidance Platform (OGP) Software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the FastPlan system result in a lateral offset error.
Firm Action
On 3/30/2011, Varian distributed an Urgent Medical Device Correction Urgent Field Safety Notice to all affected users, with a description of the problem and identification of the affected product. The letter also informed customers of how they can determine if the problem affects them. The letter states that there is no work around for the issue unless they possess a FastPlan system. Varian is preparing a software patch to correct the issue and it will be applied to all OGP v2.6 and v2.6.1 systems. Customers are to advise the appropriate personnel of the content of the letter. If further clarification is needed, customers are to contact their local Varian Customer Support District or Regional Manager.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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