FramelessArray software, Version 1.0. ; Medical Device firmware incorporated with the RadioCamera Extracranial System, d
FDA device recall Z-0905-2007 · posted 2007-06-06 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 178 devices
- Distribution
- Worldwide : The software was distributed to direct accounts in the US and internationally distributed to accounts in Canada, Australia and Spain.
- Date initiated
- 2007-03-14
- Date posted
- 2007-06-06
- Date terminated
- 2008-07-03
- Location
- Palo Alto, CA
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