Recall Z-1064-2014— Elekta, Inc.

Name: FDA recall Z-1064-2014
Creator: U.S. Food and Drug Administration
Published: 2013-05-28

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-05-28, terminated 2017-01-17. It names one FDA 510(k) clearance: K963624. Product: SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.. Reason: Customers are resetting the default values outside recommended factory settings..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Terminated: 2017-01-17
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K963624 — PHILIPS SLI SERIES LINEAR ACCELERATORPhilips Medical Systems, Inc.·cleared 1996-12-06

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

SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

Reason for recall

Customers are resetting the default values outside recommended factory settings.

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