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.
FDA Recall Z-2778-2011 · Posted 2011-07-11
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Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-05-13
Date Terminated2012-07-13
Product Quantity36
Reason for Recall
Some drive stand bolts may fail to meet mechanical specifications.
Firm Action
Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers.
The letter included a description of product, problem and recommendations. This includes performing daily QA to detect isocenter shift and the use of independent patient position system. Customers are advised to discontinue its use if a shift is detected and to contact Varian Medical Systems for a replacement stand bolts and adjustment if necessary.
For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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