FDA Medical Device Recalls (openFDA)
Brainlab AG: 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 number
- Z-1255-06
- Recalling firm
- Brainlab AG
- 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
- Status
- Terminated
- Initiated
- 2006-06-02
- Posted
- 2006-07-27
- Terminated
- 2008-02-24
- Reason
- 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.
- Root cause
- Other
- 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
- 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
- Lot, serial or model codes
- 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;
- 510(k) numbers
- ["K033316"]
- PMA numbers
- not on file
- Product code
- JAI
- Firm FEI
- 3002619595
- Firm city
- Kirchheim B. Muenchen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28