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

Is my product affected?

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

• UPC 04056481142315

Check against the official notice below — it lists the full affected range.

What happened

Brainlab AG is recalling 73 ExacTrac Dynamic systems used in charged-particle radiation therapy. The systems have a software error that can cause the display to incorrectly show that a patient's position is within acceptable limits when it may actually exceed safe shift values. This error occurs when the system fails to automatically detect position markers, potentially allowing treatment to proceed when the patient is not properly positioned.

The affected ExacTrac Dynamic systems are model 20910-06 with software versions 1.0.0, 1.0.1, or 1.0.2, and have been distributed in multiple U.S. states (California, New Jersey, Arizona, Arkansas, New York, Indiana, Oregon, and North Carolina) as well as internationally. The source document does not specify what actions affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. 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 Lot/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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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