Recall Z-0905-2007 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
FramelessArray software, Version 1.0. ; Medical Device firmware incorporated with the RadioCamera Extracranial System, distributed by Varian Medical System, Palo Alto, CA.
| Date | Jun 6, 2007 (initiated Mar 14, 2007) |
| Status | Terminated |
| Reason | Localization error; with planning data transferred to the Optical Guidance Platform via DICOM RT; The software incorrectly computes the center of the CT volume, resulting in a potential axial error ranging from 0.3 mm to 1.5 mm, affecting both Fractionated and Stereotactic Radiosurgery (SRS) Treatments |
| Root cause | Software design |
| Action | The recalling firm notified consignees by certified letter on 03/14/07. The notification was flagged as "Urgent Medical Device Correction" and advised end users that a localization error may occur when using the FramelessArray and affect its accuracy for Frameless treatments. Users were instructed to verify software in the devices and if running FramelessArray version 1.0, to discontinue use of the software when Stereotactic Radiosurgery plans are transfered via DICOM RT. The notification offered that firmware would be upgraded during scheduled service visit. |
| Quantity | 178 devices |
| Distribution | Worldwide : The software was distributed to direct accounts in the US and internationally distributed to accounts in Canada, Australia and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.