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.
Reported: May 13, 2015 Initiated: March 6, 2015 #Z-1582-2015
Product Description
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.
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.
Details
- Recalling Firm
- Brainlab AG
- Units 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
- Location
- Feldkirchen, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Brainlab AG. Units affected: 25 systems (US only); 53 systems (Foreign).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2015. Severity: Moderate. Recall number: Z-1582-2015.
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