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Terminated

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

FDA Recall Z-1255-06 · Posted 2006-07-27

Recalling FirmBrainlab AG
Recall StatusTerminated
Product CodeJAI
Date Initiated2006-06-02
Date Terminated2008-02-24
Product Quantity19 devices

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide, including the states of California, Colorado, Florida, Illinois, Maryland, Michigan, Missouri, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, Tennessee and Texas

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033316TABLE TILT DEVICEBrainlab AG · 2004-05-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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