Events

Recall of Device Recall Clinac 600C

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    31234
  • Event Risk Class
    Class 2
  • Event Number
    Z-0777-05
  • Event Initiated Date
    2005-02-04
  • Event Date Posted
    2005-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37436
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, Linear, Medical - Product Code IYE
  • Reason
    Treatment beam may not completely pause while device changes field shape; potential for mistreatment could occur.
  • 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.

Device

Device Recall Clinac 600C
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • Manufacturer Address
    Varian Medical Systems Inc, 3100 Hansen Way, M/S E-210, Palo Alto CA 94304-1030
  • Source
    USFDA