Brainlab AG Recall 89662
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.
Brainlab AG Recall 89662 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0733-2022 |
| Event ID | 89662 |
| Event 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 Type | Devices |
| 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. |
| Quantity | 205 systems |
| Recall Reason | The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. |
| Device Classification | 20220316 |
| Device Code Info | Software versions 1.0.0, 1.0.1, 1.0.2, 1.0.3, GTIN 04056481142315. |
| Center Classification Date | 20220308 |
| Recall Initiation Date | 20220225 |
| Recalling Firm | Brainlab AG |
| Initial Notification | |
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