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U.S. Department of Health and Human Services

Class 2 Device Recall Clinac 600C

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  Class 2 Device Recall Clinac 600C see related information
Date Initiated by Firm February 04, 2005
Date Posted April 27, 2005
Recall Status1 Terminated 3 on August 17, 2006
Recall Number Z-0777-05
Recall Event ID 31234
510(K)Number k926321  k904364  k862645  
Product Classification Accelerator, Linear, Medical - Product Code IYE
Product Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability
Code Information Serial numbers include 180053 180073 180076 180115 180136 180140 180145 180187 180204 180207 180221 180222 180224 180249 180255 180256 180260 180273 180274 180283 180294 180298 180311 180427 180433 180437 180448 180454 180458 180460 180463 180467 180469 180471 180473 180484 180486 180490 180491 180492 180509 180510 180512 180514 180514 180517 180519 180522 180523 180526 180528 180528 180541 180543 180549 180553 180554 180559 180560 180562 180566 180566 180569 180576 180578 180581 180588 180593 180596 180597 180600 180601 180605 180606 180607 180608 180614 180618 180619 180626 180627 180629 180630 180631 180632 180633 180640 180643 180644 180645 180648 180655 180661 180668 180669 180670 180671 180672 180674 180679 180681 180683 180684 180690 180693 180694 180695 180696 180707 180709 180710 180715 180717 180718 180719 180720 180721 180724 180725 180726 180728 180729 180733 180735 180736 180737 180741 180745 180747 180750 180753 180756 180757 180758 180759 180761 180769 180777 180778 180780 180784 180785 180787 180792 180794 180795 180796 180797 180804 180810 180815 180815 180816 180817 180821 180822 180823 180824 180825 180826 180827 180832 180831 180832 180833 180836 180837 180839 180841
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
3100 Hansen Way
M/S E-210
Palo Alto CA 94304-1030
For Additional Information Contact Mark Perkins
650-424-6640
Manufacturer Reason
for Recall		 Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 170 units
Distribution 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.
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 = VARIAN ASSOC., INC.
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