Recall Z-2157-2013— Elekta, Inc.

Name: FDA recall Z-2157-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-15

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-08-15, terminated 2015-07-28. It names one FDA 510(k) clearance: K001163. Product: DMLC IV-ERGO - Beam shaping block for Radiation Therapy.. Reason: Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-15
Terminated: 2015-07-28
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K001163 — DMLC IV-ERGO3D Line USA, Inc.·cleared 2000-10-23

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

DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

Reason for recall

Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.

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