Recall Z-1582-2015 ยท IYH Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
Brainlab AG
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
| Date | May 6, 2015 (initiated Mar 6, 2015) |
| Status | Terminated |
| Reason | ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees. |
| Root cause | Software in the Use Environment |
| Action | FIELD SAFETY / PRODUCT NOTIFICATION letters dated March 6, 2015 were sent to all customers of record. The letters included instructions for customers to: 1) With immediate effect, always make sure the couch is at exactly 0.0 degrees (displayed on the Varian monitor) when acquiring a CBCT set to import into the ExacTrac software; 2) For Varian systems providing an option to prevent a CBCT acquisition for couch angles other than 0.0 degrees, Brainlab recommends selecting that option for use in combination with ExacTrac; and, 3) Continue to verify any ExacTrac CBCT based correction using the Exac |
| Quantity | 25 systems (US only); 53 systems (Foreign) |
| Distribution | *** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120789 | EXACTRAC X-RAY X-RAY Brainlab AG, Aug 14, 2012 |