Recall Z-0172-2018 ยท IYE Accelerator, Linear, Medical
Brainlab AG
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images recei
| Date | Nov 3, 2017 |
| Status | Terminated |
| Reason | Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed. |
| Root cause | Software design |
| Action | The firm notified their consignees by email on November 3, 2017. "Instructions to customers what to do with the recalled product. For instructions for the user how to address this issue, and to avoid a patient and treatment target position potentially different than intended due to this issue, please also refer to the User Corrective Action section in the attached Field Safety Notice / Product Notification letter CAPA-20171011-001985: 1. After applying a couch shift always perform a verification image of the patient position before enabling the treatment beam. 2. Do not use the Virtual |
| Quantity | 28 units |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Belgium, Canada, France, Germany, Italy, Japan and S. Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122451 | EXACTRAC VERO Brainlab AG, Sep 28, 2012 |