ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING
FDA device recall Z-1513-2014 · posted 2014-04-25 · Terminated
Recall details
- Recalling firm
- Brainlab AG
- Reason for recall
- When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position.
- Action taken
- A FIELD SAFETY NOTICE / PRODUCT INFORMATION letters, dated February 24, 2014, were sent to all direct accounts. The letter identified the affected product, the reason for the recall, and included instructions for direct accounts to take while a permanent fix can be deployed. The letter also advised that a software update will be made available starting the end of April 2014. Customers with questions or concerns can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 41 systems (13 systems in US; 28 systems to foreign countries)
- Distribution
- Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France, Germany, Japan, Netherlands, and the United Kingdom.
- Date initiated
- 2014-02-24
- Date posted
- 2014-04-25
- Date terminated
- 2017-04-24
- Location
- Feldkirchen, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTRAC X-RAY X-RAY (K120789) | Brainlab AG | 2012-08-14 |