FDA recall Z-0733-2022

Brainlab AG · Class II · 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.

Reason for recall

The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2022-02-25
Report date
2022-03-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Munich, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0733-2022