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Brainlab AG Recall 87395

Description: ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

Brainlab AG Recall 87395 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1185-2021
Event ID87395
Event DescriptionExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Product TypeDevices
DistributionUSA: (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.
Quantity73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed
Recall ReasonIn 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 Classification20210317
Device Code InfoModel/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 Date20210308
Recall Initiation Date20210301
Recalling FirmBrainlab AG
Initial Notification E-Mail
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