Recall Z-1255-06 ยท JAI Couch, Radiation Therapy, Powered
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
| Date | Jul 27, 2006 (initiated Jun 2, 2006) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033316 | TABLE TILT DEVICE Brainlab AG, May 14, 2004 |