ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical a
FDA device recall Z-1582-2015 · posted 2015-05-06 · Terminated
Recall details
- Recalling firm
- Brainlab AG
- Reason for recall
- 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.
- Action taken
- 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 ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. The letters further advised that Brainlab will be taking the following actions: 1. Brainlab provides existing potentially affected ExacTrac v.6.x CBCT Import & Alignment Software customers (with a Varian C-Series linac) with this product notification information; and, 2. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact the customers starting August 2015 to schedule the update installation. Customers with questions about this issue were advised to contact Brainlab at 800-597-5911 or via e-mail by writing at us.support@brainlab.com.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- IYH
- Quantity affected
- 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
- Date initiated
- 2015-03-06
- Date posted
- 2015-05-06
- Date terminated
- 2017-04-24
- Location
- Feldkirchen, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTRAC X-RAY X-RAY (K120789) | Brainlab AG | 2012-08-14 |