Recall Z-1929-2016— Brainlab AG

Name: FDA recall Z-1929-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-04

Class II · Terminated

Class II FDA medical device recall by Brainlab AG, initiated 2016-05-04, terminated 2017-07-24. It names one FDA 510(k) clearance: K122451. Product: ExacTrac Vero is a Patient Positioning System for Radiation therapy.. Reason: Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5.

Recalling firm: Brainlab AG
Classification: Class II
Status: Terminated
Initiated: 2016-05-04
Terminated: 2017-07-24
Firm location: Feldkirchen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K122451 — EXACTRAC VEROBrainlab AG·cleared 2012-09-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ExacTrac Vero is a Patient Positioning System for Radiation therapy.

Reason for recall

Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5

Data sourced from openFDA. This site is unofficial and independent of the FDA.