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.
- Recall Initiated
- May 14, 2021
- Terminated
- March 20, 2023
- Recall Number
- Z-1846-2021
- Quantity
- 22 systems in the U.S.
Reason for Recall
Display of potential patient movement might be delayed to the user for high dose treatments.
Distribution
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.
Lot / Code Info
Version 1.02, GTIN 04056481142315
Root Cause
Software design
Action Taken
An Urgent Field Safety Notice/Product Notification dated 4/29/2021 was issued on 5/14/2021 via email explaining the safety issue and letting the customer know that this issue is in addition to the previous notification of 9/8/2020 which has now expanded to versions 1.0.1 and 1.0.2.
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