ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
FDA Recall Z-1185-2021 · Posted None
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Recalling FirmBrainlab AG
Recall StatusTerminated
Product CodeIYE
Date Initiated2021-03-01
Date Terminated2023-03-20
Product Quantity73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed
Reason for Recall
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.
Firm 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 implemented before clinical use by the facility (to be adhered to by the users).
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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