ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Enforcement
- Recall Number
- Z-1707-2014
- Event ID
- 67926
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Brainlab AG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 11, 2014
- Initiation Date
- April 15, 2014
- Classification Date
- June 3, 2014
- Termination Date
- April 24, 2017
- Address
- Kapellenstrasse 12, Feldkirchen, N/A, Germany
Description
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
ExacTrac software version 5.5.5 is included in the following model / catalog numbers: 1) 20818B ET SOFTWARE 5.5.5; 2) 20820 ET SOFTWARE UPDATE 5.0 TO 5.5; 3) 49905D EXACTRAC COMPLETE SYSTEM UPG 3.X TO 5.5; 4) 49908C EXACTRAC SOFTWARE UPGRADE 3.X TO 5.5; 5) 49909A EXACTRAC SOFTWARE UPGRADE 4.X TO 5.5; 6) 49918 ET SOFTWARE UPDATE 5.5.X TO 5.5.5; 7) 49919 ET SOFTWARE UPDATE 5.0.X TO 5.5.5; 8) 49660A ET INFRARED SOFTWARE 5.5.5; 9) 49961 ET DATA PREP/REVIEW SYSTEM; 10) 49986 ET SYSTEM UPGRADE 3.X TO 5.5 NEW VAULT; 11) 49987 ET SYSTEM UPGRADE 4.X TO 5.5 NEW VAULT; 12) 49988 ET SYSTEM UPGRADE 4.X TO 5.5 SAME VAULT; 13) 49989 ET SYSTEM UPGRADE 5.0 TO 5.5 NEW VAULT; 14) 49990 ET SYSTEM UPGRADE 5.0 TO 5.5 SAME VAULT; 15) 49991 ET SYSTEM UPGRADE 5.5 TO 5.5 NEW VAULT
Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan
40 systems (worldwide)