Recall Z-2200-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
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.
| Date | May 16, 2011 (initiated Mar 30, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| 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 |
| Quantity | 598 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071360 | OPTICAL GUIDANCE PLATFORM Varian Medical Systems, Inc., Jun 8, 2007 |