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.
Recall
- Recall Number
- Z-2200-2011
- Event Number
- 58505
- Firm
- Varian Medical Systems, Inc. Oncology Systems
- FEI Number
- 2916710
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- March 30, 2011
- Posted
- May 16, 2011
- Terminated
- June 19, 2012
- Address
- 911 Hansen Way, Palo Alto, CA, 94304-1028
Description
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.
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.
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.
Worldwide Distribution
598 units