Recall Z-2146-2014— Brainlab AG

Name: FDA recall Z-2146-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-24

Class II · Terminated

Class II FDA medical device recall by Brainlab AG, initiated 2014-06-24, terminated 2017-04-24. It names one FDA 510(k) clearance: K120789. Product: ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.. Reason: When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position..

Recalling firm: Brainlab AG
Classification: Class II
Status: Terminated
Initiated: 2014-06-24
Terminated: 2017-04-24
Firm location: Feldkirchen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K120789 — EXACTRAC X-RAY X-RAYBrainlab AG·cleared 2012-08-14

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 is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

Reason for recall

When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.

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