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.
FDA Recall Z-1846-2021 · Posted None
Advertisement
Recalling FirmBrainlab AG
Recall StatusTerminated
Product CodeIYE
Date Initiated2021-05-14
Date Terminated2023-03-20
Product Quantity22 systems in the U.S.
Reason for Recall
Display of potential patient movement might be delayed to the user for high dose treatments.
Firm Action
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.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement