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.
Reported: March 16, 2022 Initiated: February 25, 2022 #Z-0733-2022
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.
Details
- Recalling Firm
- Brainlab AG
- Units Affected
- 205 systems
- 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.
- Location
- Munich, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Brainlab AG. Units affected: 205 systems.
Why was this product recalled? ▼
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 16, 2022. Severity: Moderate. Recall number: Z-0733-2022.
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