Z-1255-06

ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for...

Name: Z-1255-06 ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for...
Creator: Brainlab AG
Published: 2006-06-02
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2006-06-02 / Terminated / root cause: manufacturing process

FDA source

Brainlab AG began a recall of 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... on 2006-06-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1255-06
Status: Terminated
Initiated: 2006-06-02
Posted: 2006-07-27
Terminated: 2008-02-24
Recalling firm: Brainlab, Inc.
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
Product code: JAI Couch, Radiation Therapy, Powered
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.
Root cause tag: manufacturing process
FDA 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 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
Product codes and lots: 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;

Product code JAI

K033316Class IITable Tilt DeviceBrainlab AG / cleared 2004-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)