Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators
FDA Recall Z-1375-06 · Posted 2006-08-05
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Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2005-09-20
Date Terminated2006-11-21
Product Quantity58 units
Reason for Recall
A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators .
Firm Action
On 09/20/2005, Varian Medical Systems issued a notification letter via certified mail and FedEx. These letters were issued with instructions on what to do regarding the corrections. Varian Medical Systems intends to release new, updated software.
Root Cause
Software design
Distribution Pattern
The product was distributed to 34 consignees, located in AZ, CA, MA, MI, NC, PA in the USA, and in Australia, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Lithuania, Spain, Sweden, and the United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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