Z-1259-2023 Class II Ongoing
FDA device recall Z-1259-2023 was initiated by Brainlab AG on February 14, 2023 and is designated Class II. Reason for recall: Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template The recall status is ongoing. Affected quantity: 56 systems in the U.S..
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2023
- Initiation Date
- February 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 systems in the U.S.
Product Description
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Reason for Recall
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
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.
Code Information
Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.