Recall Z-1185-2021 ยท IYE Accelerator, Linear, Medical
Brainlab AG
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
| Date | Mar 1, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | The Field Safety Notice / Product Notification Letter CAPA-20210210-002387 was distributed via email on 03/01/2021. An active reply by the consignees will be followed, if necessary via further different communication media. For future customers/facilities/systems (new installations or updates/upgrades): As of February 23, 2021: - the Field Safety Notice / product notification information is handed over to the customer during installation (before clinical use) by the according Brainlab Service representative, - a confirmation is required that the contained User Corrective Actions will be impl |
| Quantity | 73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201276 | ExacTrac Dynamic Brainlab AG, Jul 13, 2020 |