Recall Z-1869-2014— Elekta, Inc.

Name: FDA recall Z-1869-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-29

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2014-05-29, terminated 2021-07-16. It names one FDA 510(k) clearance: K123230. Product: MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.. Reason: MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-29
Terminated: 2021-07-16
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 MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.

Reason for recall

MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order.

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