Recall Z-0130-2016— Elekta, Inc.

Name: FDA recall Z-0130-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-31

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2015-08-31, terminated 2021-09-15. It names one FDA 510(k) clearance: K102216. Product: XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.. Reason: Incorrect Treatment Delivery Using Third Party Fixed Wedges..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-08-31
Terminated: 2021-09-15
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K102216 — XIO RTP SYSTEMComputerized Medical Systems, Inc.·cleared 2010-10-01

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

XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

Reason for recall

Incorrect Treatment Delivery Using Third Party Fixed Wedges.

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