Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA The product is a radiation treatment planning system.
FDA Recall Z-2195-2008 · Posted 2008-09-16
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Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-05-29
Date Terminated2011-05-03
Product Quantity182
Reason for Recall
Due to issues with image orientation verification, a patient may receive all or some of prescribed high dose to healthy tissue instead of intended area.
Firm Action
Recall was initiated by the firm on 05/29/2008. A product notification letter /field safety letter was distributed to all affected users, with a description of the problem and user corrective action steps. In addition, the letter will also be distributed to Varian Sales, Marketing and Service Organizations. Letters were sent to consignees via certified mail with return receipt mailing to US consignees. For foreign consignees, letters will be translated as necessary and distributed with return proof of notification. Varian Medical can be contacted at 1-650-483-3153 for assistance.
Root Cause
Labeling False and Misleading
Distribution Pattern
Product was distributed throughout the US and to Australia, Brazil, Chile, France, Germany, Hong Kong, India, Israel, Japan, China, Malaysia, Russian Federation, Singapore and Spain.
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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