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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 076 08 12 000
Date submitted: 8/27/2012
Manufacturer:Varian Medical Systems
Device Type:Accelerator System, Linear, Clinac, Trilogy,
Description:Accelerator System, Linear
Medical Device Identifier:SERIAL NUMBERS: H140863 H294608 H294669 H294732 H140865 H294610 H294670 H294733 H140866 H294611 H294671 H294734 H140867 H294612 H294672 H294735 H140868 H294613 H294673 H294736 H140869 H294614 H294674 H294737 H140870 H294615 H294675 H294738 H140871 H294616 H294676 H294739 H140872 H294617 H294677 H294740 H140873 H294618 H294678 H294741 H140874 H294619 H294679 H294742 H140875 H294620 H294680 H294743 H140876 H294621 H294681 H294744 H140877 H294622 H294682 H294745 H140878 H294623 H294683 H294746 H140879 H294624 H294684 H294747 H140880 H294625 H294685 H294748 H140881 H294626 H294686 H294749 H140882 H294627 H294687 H294750 H140883 H294628 H294688 H294751 H140884 H294629 H294689 H294752 H140885 H294630 H294690 H294753 H140886 H294631 H294691 H294754 H140887 H294632 H294692 H294755 H140888 H294633 H294693 H294756 H140889 H294634 H294694 H294757 H140890 H294635 H294695 H294758 H140891 H294636 H294696 H294759 H140892 H294637 H294697 H294760 H140893 H294638 H294698 H294761 H140895 H294639 H294699 H294762 H140896 H294640 H294700 H294763 H140897 H294641 H294701 H294764 H140898 H294642 H294702 H294765 H140899 H294643 H294704 H294766 H140900 H294644 H294705 H294767 H181175 H294645 H294706 H294768 H181176 H294646 H294707 H294769 H181177 H294647 H294708 H294770 H181178 H294648 H294709 H294771 H181179 H294649 H294710 H294772 H181180 H294650 H294711 H181181 H294651 H294712 H181182 H294652 H294713 H181183 H294653 H294714 H181184 H294654 H294715 H181185 H294655 H294716 H181186 H294656 H294717 H181187 H294657 H294718 H181188 H294658 H294719 H181189 H294659 H294720 H181190 H294660 H294722 H181191 H294661 H294723 H181192 H294662 H294724 H182000 H294663 H294726 H182001 H294664 H294727 H182002 H294665 H294728 H182003 H294666 H294729 H182005 H294667 H294730 H294607 H294668 H294731
Reason of Field Safety Corrective Action:an anomaly that has been identified with the Clinac, Trilogy, Novalis Tx and Unique jaw carriers. The jaw carriers function to couple the X-jaws to their respective drive screw mechanisms used for controlling field size (refer to Figure 1(attached). Some jaw carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. If both jaw carriers on the same X-jaw were to crack, the jaw would be able to move freely in the closed direction. In this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry. Treatment after such a failure occurs may lead to an underdose of the intended target volume
Remedy Action:Immediately contact your Varian local service organization when abnormal noises are observed in the collimator head while rotating the Gantry or Collimator. • Verify the jaw position prior to the treatment of every field. This is typically done using portal imaging or field light projection. A Varian Medical Systems Customer Support Service representative will schedule a visit to inspect and replace the jaw carriers on your system as necessary
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCMDR
Source Ref. Number:11BFB4AA872B5
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems.pdf