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U.S. Department of Health and Human Services

Class 2 Device Recall ExacTrac Robotics

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  Class 2 Device Recall ExacTrac Robotics see related information
Date Initiated by Firm June 02, 2006
Date Posted July 27, 2006
Recall Status1 Terminated 3 on February 24, 2008
Recall Number Z-1255-06
Recall Event ID 35742
510(K)Number K033316  
Product Classification table - Product Code JAI
Product ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; a table tilt device - powered radiation therapy patient support assembly; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany
Code Information bundle #06-69448-49700, tilt module #3520-05-011-49720; bundle #06-69445-49700, tilt module #3520-05-006-49720; bundle #06-78573-49700, tilt module #3520-05-017-49720; bundle #06-69573-49700, tilt module #3520-05-002-49720; bundle #06-78149-49700, tilt module #3520-05-015-49720; bundle #06-66427-49700, tilt module #3520-05-013-49720; bundle #06-62416-49700, tilt module #3520-05-008-49720;  tilt module #3520-05-018-49720;  bundle #06-77290-49700, tilt module #3520-05-019-49720; bundle #06-77669-49700, tilt module #3520-05-020-49720; bundle #06-78440-49700, tilt module #3520-05-014-49720; bundle #06-74601-49700, tilt module #3520-05-010-49720; bundle #06-64377-49700, tilt module #7520-05-005-49720;
Recalling Firm/
Brainlab AG
Ammerthalstrasse 8
Kirchheim B. Muenchen Germany
For Additional Information Contact Ms. Kate Franco
Manufacturer Reason
for Recall
During ExacTrac Robotics installation on the Varian Exact Couch, the couch height position indication is re-calibrated to read out the correct positions. This re-calibration could cause the eventual failure of the vertical lift mechanism of the couch, which might result in patient injury or death.
FDA Determined
Cause 2
Action BrainLab issued a Product Notification Letter to the hospitals on 6/2/06 to advise the users not to lower the couch below 50 cm, and sent a second letter to the users on 6/7/06, informing them that BrainLab would remove the ExacTrac Robotics from the Exact Couch and re-calibrate the couch to restore the software limit switch. The Robotics will be re-installed once a permanent solution is available.
Quantity in Commerce 19 devices
Distribution Nationwide, including the states of California, Colorado, Florida, Illinois, Maryland, Michigan, Missouri, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, Tennessee and Texas
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAI and Original Applicant = BRAINLAB AG