Recall Z-0731-2017— Elekta, Inc.

Name: FDA recall Z-0731-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-02

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2016-12-02, terminated 2021-11-05. It names one FDA 510(k) clearance: K141572. Product: MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.. Reason: Edits to Particle field definition parameters may not be saved when the field definition window is saved..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-12-02
Terminated: 2021-11-05
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K141572 — MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc.·cleared 2014-09-05

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 Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.

Reason for recall

Edits to Particle field definition parameters may not be saved when the field definition window is saved.

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