Z-1846-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- May 14, 2021
- Termination Date
- March 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 systems in the U.S.
Product Description
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Reason for Recall
Display of potential patient movement might be delayed to the user for high dose treatments.
Distribution Pattern
US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.
Code Information
Version 1.02, GTIN 04056481142315