Recall Z-0138-2014— Elekta, Inc.

Name: FDA recall Z-0138-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-23

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-07-23, terminated 2014-11-18. It names one FDA 510(k) clearance: K011255. Product: Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.. Reason: Potential for clinical errors..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-23
Terminated: 2014-11-18
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K011255 — 3D LINE STEROTACTIC HARDWARE ACCESSORIES3D Line USA, Inc.·cleared 2001-12-20

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

Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.

Reason for recall

Potential for clinical errors.

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