Recall Z-0221-2015— Elekta, Inc.

Name: FDA recall Z-0221-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-03

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2014-11-03, terminated 2015-07-27. It names one FDA 510(k) clearance: K123230. Product: MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.. Reason: A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-03
Terminated: 2015-07-27
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K123230 — MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc.·cleared 2012-12-12

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

MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

Reason for recall

A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.

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