Device Recall Clinac

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

Radiology Devices

2

No

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.

Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability

Affected Serial Numbers: H140001, H140002, H140003, H140004, H140005, H140006, H140007, H140009, H140022, H140010, H14001, H140012, H140013, H140014, H140015, H140016, H140017, H140018, H140019, H140021, H140023, H140024, H140025.

Radiology Devices

2

No

US distribution is: CA, CT, IL, IN, KY, OH, MI, NC, NJ, NY, SC, TN, TX, VA, & WA, totaling 22 hospitals. Foreign distribution includes: Denmark, Hong Kong, and Japan. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers.

Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); || Distributed by and/or Manufactured by: Varian Medical Systems, Palo Alto, CA 94304.

All lots

Radiology Devices

2

No

Worldwide

Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D, 21 EX. 2300 C/D, 23 EX, 600C, 600 C/D, 2500 C, Trilogy, 6EX and Silhouette.

Serial numbers H272325, H291060, H271879, H273040, H272187, H272434

Radiology Devices

2

No

Worldwide, including USA, England, Taiwan, Switzerland, Sweden, South Korea, Portugal, Poland, Norway, New Zealand, Netherlands, Malaysia, Japan, Italy, Germany, France, Denmark, Czech Republic, Colombia, China, Canada, Belgium, Australia and Venezuela.

Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX)

H14, H19, H27, H29. Serial Numbers:  H140927 H191045 H294986 H295004 H295021 H295036 H140929 H191048 H294988 H295010 H295025 H295042 H140932 H191049 H294989 H295012 H295031 H295047 H140934 H191050 H294999 H295013 H295032 H295051 H191035 H272973 H295001 H295014 H295033 H295058 H191044 H294979 H295002 H295015 H295034 H295068

Radiology Devices

2

No

Worldwide distribution: (USA) Nationwide including the states of PA. NJ, NY, MA, VA, TX, KS, FL, OH, SC, MN, CA, TN and NV; and the countries of Canada, Colombia, France, Italy, Japan, Netherlands and United Kingdom.

Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands || Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.