Recall Z-1846-2021 ยท IYE Accelerator, Linear, Medical
Brainlab AG
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, tumor
| Date | May 14, 2021 |
| Status | Terminated |
| Reason | Display of potential patient movement might be delayed to the user for high dose treatments. |
| Root cause | Software design |
| 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. |
| Quantity | 22 systems in the U.S. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203173 | ExacTrac Dynamic Brainlab AG, Nov 12, 2020 |