Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Class I - DangerousWhat Should You Do?
- Check if you have this product: LIST OF 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Varian Medical Systems, Inc. Oncology Systems
- Reason for Recall:
- Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The position readout interlock circuitry will not detect this jaw position deviation. This may lead to treatment with an under-dose of the intended target volume.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Product Codes/Lot Numbers:
LIST OF 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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2383-2012
Related Recalls
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Varian Medical Systems, Inc. Oncology Systems
Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.
Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
Varian Medical Systems, Inc. Oncology Systems
Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Varian Medical Systems, Inc. Oncology Systems
The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.