Brainlab AG: Medical Device Recall in 2022 - (Recall #: Z-0733-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 25, 2022

Date Posted: March 16, 2022

Recall Number: Z-0733-2022

Event ID: 89662

Reason for Recall:

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

Status: Ongoing

Product Quantity: 205 systems

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.

Voluntary or Mandated:

Voluntary: Firm initiated