FramelessArray software, Version 1.0. ; Medical Device firmware incorporated with the RadioCamera Extracranial System, distributed by Varian Medical System, Palo Alto, CA.
FDA Recall Z-0905-2007 · Posted 2007-06-06
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Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2007-03-14
Date Terminated2008-07-03
Product Quantity178 devices
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
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide : The software was distributed to direct accounts in the US and internationally distributed to accounts in Canada, Australia and Spain.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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