Z-1929-2016 Class II Terminated
FDA device recall Z-1929-2016 was initiated by Brainlab AG on May 4, 2016 and is designated Class II. Reason for recall: Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 The recall status is terminated (terminated July 24, 2017). Affected quantity: 27 Systems.
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2016
- Initiation Date
- May 4, 2016
- Termination Date
- July 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 Systems
Product Description
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Reason for Recall
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
Distribution Pattern
Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.
Code Information
Potentially affected is ExacTrac Vero version 3.5 (including all subversions). Serial numbers/lot numbers are not applicable for a software version. Model/catalogue numbers: 20892 EXACTRAC VERO SOFTWARE 3.5 20892A EXACTRAC VERO SOFTWARE 3.5.1 20892B EXACTRAC VERO SOFTWARE 3.5.2 20892C EXACTRAC VERO SOFTWARE 3.5.3 20893 VERO INFRARED POSITIONING/MONITORING SW 46213 EXACTRAC VERO SW UPDATE 3.5 TO 3.5.1 46214 EXACTRAC VERO UPGRADE KIT 3.2 to 3.5 FOC 46215 EXACTRAC VERO UPGRADE KIT 3.1 TO 3.5 FOC 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46228 EXACTRAC VERO 3.5 ROW 46238 EXACTRAC VERO 3.5 JAPAN