FDA recall Z-1185-2021

Product

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

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.

Key facts

Status

Terminated

Initiation date

2021-03-01

Report date

2021-03-17

Termination date

2023-03-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Munich, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1185-2021