Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany
Lot Codes / Batch Numbers
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
Products Sold
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;
Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany is recalling ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, due to During ExacTrac Robotics installation on the Varian Exact Couch, the couch height position indication is re-calibrated to read out the correct positio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026