FDA Medical Device Recalls (openFDA)
Varian Medical Systems Inc: Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability
- Recall number
- Z-0777-05
- Recalling firm
- Varian Medical Systems Inc
- Product
- Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability
- Status
- Terminated
- Initiated
- 2005-02-04
- Posted
- 2005-04-27
- Terminated
- 2006-08-17
- Reason
- Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K862645","K904364","K926321"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28