Brainlab AG Recall 87984
Description: ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Brainlab AG Recall 87984 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1846-2021 |
| Event ID | 87984 |
| Event Description | ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution. |
| Quantity | 22 systems in the U.S. |
| Recall Reason | Display of potential patient movement might be delayed to the user for high dose treatments. |
| Device Classification | 20210616 |
| Device Code Info | Version 1.02, GTIN 04056481142315 |
| Center Classification Date | 20210610 |
| Recall Initiation Date | 20210514 |
| Recalling Firm | Brainlab AG |
| Initial Notification | Letter |
| Similar To |