Device product
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Z-1259-2023
Product summary
- Firm
- Brainlab AG
- Event
- Event 91664
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 56 systems in the U.S.
- Official record key
device-enforcement:Z-1259-2023
Official wording
Reason: Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Code information: Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template