ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on
FDA device recall Z-1255-06 · posted 2006-07-27 · Terminated
Recall details
- Recalling firm
- Brainlab AG
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAI
- Quantity affected
- 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
- Date initiated
- 2006-06-02
- Date posted
- 2006-07-27
- Date terminated
- 2008-02-24
- Location
- Kirchheim B. Muenchen, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TABLE TILT DEVICE (K033316) | Brainlab AG | 2004-05-14 |