Z-0733-2022 Class II Ongoing
FDA device recall Z-0733-2022 was initiated by Brainlab AG on February 25, 2022 and is designated Class II. Reason for recall: The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. The recall status is ongoing. Affected quantity: 205 systems.
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2022
- Initiation Date
- February 25, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 205 systems
Product Description
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.
Reason for Recall
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
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.
Code Information
Software versions 1.0.0, 1.0.1, 1.0.2, 1.0.3, GTIN 04056481142315.