Recall Z-2440-2015 ยท IYE Accelerator, Linear, Medical
Brainlab AG
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
| Date | Aug 21, 2015 (initiated Aug 5, 2015) |
| Status | Terminated |
| Reason | ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification. |
| Root cause | Software in the Use Environment |
| Action | Brainlab intends to distribute the Field Safety Notice / Product Notification letter CAPA-20150713-001446, dated July 20, 2015, to the customers. The letter provides instructions for the user on how to address this issue, and to avoid a patient and treatment target position potentially different than intended due to this issue. The Field Safety Notice / Product Notification letter states that as generally required, always verify that the correct DRRs for the current patient are displayed in ExacTrac and an accurate fusion to the X-Ray images is possible for patient positioning. In case in |
| Quantity | 361 systems |
| Distribution | Worldwide Distribution - USA including the states of AL, AZ, AK, CA CO, CT, FL, GA, ID, IL IN, KY, LA, MD, MA, MI, MN, NE, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and, the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hong Kon |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120789 | EXACTRAC X-RAY X-RAY Brainlab AG, Aug 14, 2012 |