Class 2 Device Recall FastPlan, Verison 5.5 or 5.5.1

• Date Initiated by Firm: May 29, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on May 03, 2011
• Recall Number: Z-2195-2008
• Recall Event ID: 48654
• 510(K)Number: K962792
• Product Classification: Radiation Treatment Planning system - Product Code IYE
• Product: 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.
• Code Information: Serial numbers HZ30495 HZ30077 HZ39010 HZ30021 HZ30398 HZ30540 HZ30698 HZ32020 HZ32054 HZ38006 HZ30258 HZ30110 HZ39011 HZ30033 HZ30403 HZ30556 HZ30703 HZ32021 HZ32056 HZ38062 HZ30737 HZ30111 HZ39012 HZ30054 HZ30404 HZ30557 HZ30727 HZ32024 HZ32058 HZ39018 HZ30273 HZ30112 HZ39013 HZ30061 HZ30407 HZ30571 HZ30731 HZ32026 HZ32059 HZ39066 HZ32023 HZ30154 HZ39014 HZ30131 HZ30422 HZ30572 HZ30740 HZ32028 HZ32060 HZ39071 HZ39019 HZ30181 HZ39015 HZ30144 HZ30426 HZ30574 HZ30762 HZ32029 HZ32062 HZ39165 HZ30630 HZ30182 HZ39016 HZ30171 HZ30460 HZ30588 HZ32001 HZ32032 HZ32063 HZ39997 HZ32045 HZ30190 HZ30178 HZ30207 HZ30461 HZ30612 HZ32002 HZ32033 HZ32064 HZ39998 HZ32046 HZ30368 HZ30283 HZ30208 HZ30462 HZ30617 HZ32004 HZ32034 HZ32065 HZ30743 HZ30108 HZ30500 HZ30167 HZ30224 HZ30485 HZ30620 HZ32005 HZ32035 HZ32069 HZ32025 HZ30139 HZ30712 HZ32019 HZ30230 HZ30507 HZ30640 HZ32006 HZ32036 HZ32071 HZ32027 HZ30594 HZ32013 HZ30280 HZ30251 HZ30508 HZ30646 HZ32007 HZ32037 HZ32072 HZ30624 HZ32052 HZ30573 HZ30265 HZ30509 HZ30649 HZ32008 HZ32044 HZ32073 HZ30604 HZ39001 HZ32040 HZ30293 HZ30510 HZ30656 HZ32010 HZ32047 HZ32074 HZ32003 HZ39002 HZ32061 HZ30294 HZ30511 HZ30670 HZ32012 HZ32048 HZ32077 HZ30219 HZ39004 HZ30032 HZ30312 HZ30513 HZ30674 HZ32014 HZ32049 HZ35070 HZ30019 HZ39005 HZ30730 HZ30330 HZ30520 HZ30675 HZ32016 HZ32050 HZ36101 HZ30044 HZ39006 HZ32009 HZ30342 HZ30531 HZ30681 HZ32017 HZ32051 HZ36102 HZ30058 HZ39007 HZ30001 HZ30349 HZ30537 HZ30684 HZ32018 HZ32053 and HZ37015
• Recalling Firm/ Manufacturer: Varian Medical Systems Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: 650-424-5731
• Manufacturer 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.
• FDA Determined Cause: Labeling False and Misleading
• 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.
• Quantity in Commerce: 182
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE and Original Applicant = SURGICAL NAVIGATION TECHNOLOGIES, INC.