Recall Z-0928-2014— Elekta, Inc.

Name: FDA recall Z-0928-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-25

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-11-25, terminated 2015-12-02. It names one FDA 510(k) clearance: K102216. Product: XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.. Reason: When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Terminated: 2015-12-02
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 RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

Reason for recall

When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.

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