Recall Z-1259-2023 ยท IYE Accelerator, Linear, Medical
Brainlab AG
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
| Date | Mar 16, 2023 (initiated Feb 14, 2023) |
| Status | Open, Classified |
| Reason | Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template |
| Root cause | Software design |
| Action | The recalling firm issued letters dated 1/25/2023 via email and were flagged URGENT FIELD SAFETY NOTICE / PRODUCT NOTIFICATION. The letter provides the user information on how the issue occurs and informs them of the corrective actions Brainlab is taking to address the issue. Detailed information on the issue and its effects are provided. The letter provides User Corrective Actions: (1) Always create DIBH Treatment Templates from the Brainlab provided DIBH Master Templates; and (2) Always ensure that Beam Hold Control is enabled ("On") before proceeding to DIBH treatment. Brainlab will pr |
| Quantity | 56 systems in the U.S. |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220338 | ExacTrac Dynamic Brainlab AG, Apr 29, 2022 |