Recall Z-1707-2014 ยท IYE Accelerator, Linear, Medical
Brainlab AG
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
| Date | Jun 3, 2014 (initiated Apr 15, 2014) |
| Status | Terminated |
| Reason | When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient. |
| Root cause | Software design |
| Action | Brainlab sent a "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" letter dated March 13, 2014 was sent to all affected customers. The letter identifies the affected product, problem, and actions to be taken. The letter includes specific instructions to users that are intended to reduce the likelihood of similar events occurring when using ExacTrac software version 5.5.5. The letter further states that Brainlab will be providing a software update to all customers. Brainlab will contact all customers to arrange for the software update within the following 6 months. Customers with any questions ab |
| Quantity | 40 systems (worldwide) |
| Distribution | Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072506 | EXACTRAC 5.5 Brainlab AG, Oct 26, 2007 |