Recall Z-2052-2016— Elekta, Inc.

Name: FDA recall Z-2052-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-17

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2016-06-17, terminated 2020-08-18. It names one FDA 510(k) clearance: K141572. Product: MOSAIQ Oncology Information System. Reason: It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-06-17
Terminated: 2020-08-18
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

Reason for recall

It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.

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