Device product
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
Z-0733-2022
Product summary
- Firm
- Brainlab AG
- Event
- Event 89662
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 205 systems
- Official record key
device-enforcement:Z-0733-2022
Official wording
Reason: The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Code information: Software versions 1.0.0, 1.0.1, 1.0.2, 1.0.3, GTIN 04056481142315.
Distribution pattern: Distribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, and WA. There was no government or military distribution. Foreign distribution was made to Australia, Austria, Bahrain, Belgium, China, Denmark, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, New Zealand, Poland, Singapore, Slovakia, South Korea, Spain, Thailand, Turkey, United Kingdom, and United Arab Emirates.
Derived failure modes
-
Unknown
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.