Recall Z-2146-2014 ยท IYE Accelerator, Linear, Medical
Brainlab AG
ExacTrac is 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, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
| Date | Aug 4, 2014 (initiated Jun 24, 2014) |
| Status | Terminated |
| Reason | When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position. |
| Root cause | Software design |
| Action | Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated June 24, 2014, to all affected customers. The letter included instructions for customers to: 1) Avoid using plans with multiple isocenters in ExacTrac 6.0.4 whenever possible, and 2) If plans with multiple isocenters cannot be avoided and such a plan is used in ExacTrac v.6.0.4, then always select "Yes" in the dialog displayed to "keep the previous correction shift" when switching between isocenters and always verify all final treatment positions. Brainlab will provide a software update with this issue solved to affec |
| Quantity | 15 systems |
| Distribution | Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120789 | EXACTRAC X-RAY X-RAY Brainlab AG, Aug 14, 2012 |