Recall Z-1929-2016 ยท IYE Accelerator, Linear, Medical
Brainlab AG
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
| Date | May 4, 2016 |
| Status | Terminated |
| Reason | Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 |
| Root cause | Device Design |
| Action | A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION was sent to customers on May 4, 2016 and distributed via email. An active reply by the consignees will be followed, if necessary via further different communication media. As of now for new installations - the Product Notification letter is handed over to the customer during installation (before clinical use) by the according Brainlab Service representative, - a signature is required by the customer that the contained User Corrective Action will be implemented before clinical use by the facility (to be adhered to by the users). Brainlab Instructio |
| Quantity | 27 Systems |
| Distribution | Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122451 | EXACTRAC VERO Brainlab AG, Sep 28, 2012 |