Brainlab AG recalls ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical…

Recall date

March 6, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1582-2015

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

*** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.