Brainlab AG: Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.

Hazard

Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

Details from the source

Reason for recall: Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template Distribution: US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN, KY, LA, MS, MO, NJ, NY, NC, ND, OK, OR, PA, TN, TX, VA, and WA. There was no government/military distribution. Quantity: 56 systems in the U.S. Lot/code info: Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.

UPC codes

04056481143978

Source

Official record: FDA (Device enforcement) ↗

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