Recall Z-1197-2014— Elekta, Inc.

Name: FDA recall Z-1197-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-17

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2014-02-17, terminated 2015-07-21. It names one FDA 510(k) clearance: K102216. Product: XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.. Reason: Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-02-17
Terminated: 2015-07-21
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 RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.

Reason for recall

Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.

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