Brainlab AG Recall 87395
Description: ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Brainlab AG Recall 87395 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1185-2021 |
| Event ID | 87395 |
| Event Description | ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). |
| Product Type | Devices |
| Distribution | USA: (CA, NJ, AZ, AR, NY, IN, OR, NC), Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates. |
| Quantity | 73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed |
| Recall Reason | In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values. |
| Device Classification | 20210317 |
| Device Code Info | Model/catalogue numbers: 20910-06 ETD Implanted lic. UDI: The GTIN for ExacTrac Dynamic version 1.0 is 04056481142315. GMDN code: 40887. Software revisions of affected ExacTrac Dynamic software: versions 1.0.0, 1.0.1, 1.0.2. |
| Center Classification Date | 20210308 |
| Recall Initiation Date | 20210301 |
| Recalling Firm | Brainlab AG |
| Initial Notification | |
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