Recall Z-2002-2012— Elekta, Inc.

Name: FDA recall Z-2002-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-21

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2012-06-21, terminated 2014-04-01. It names one FDA 510(k) clearance: K013112. Product: Focal SIM Planning of radiation therapy. Reason: Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-06-21
Terminated: 2014-04-01
Firm location: Norcross, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K013112 — FOCAL SIMComputerized Medical Systems, Inc.·cleared 2001-12-05

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

Focal SIM Planning of radiation therapy

Reason for recall

Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

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