Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability
FDA Recall Z-0777-05 · Posted 2005-04-27
Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2005-02-04
Date Terminated2006-08-17
Product Quantity170 units
Reason for Recall
Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.
Firm Action
On 2/4/05, the firm issued letters to all its direct consignees, informing them of the affected product and providing instructions on the device correction.
Root Cause
Software design
Distribution Pattern
The firm has indicated that product was released for distribution to 143 direct consignees in US and to 25 foreign countries via international distribution centers. Foreign distribution include: Australia, Bahrain, Belgium, Canada, Czech Republic, Egypt, Finland, France, Germany, Iceland, India, Israel, Italy, Japan, Kazakhstan, Latvia, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, and 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.