Recall Z-2917-2018— Elekta, Inc.

Name: FDA recall Z-2917-2018
Creator: U.S. Food and Drug Administration
Published: 2018-08-03

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2018-08-03, terminated 2024-09-23. It names one FDA 510(k) clearance: K141572. Product: MOSAIQ Oncology Information System. Reason: Order Status Remains Approved When Should Indicate Complete..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-03
Terminated: 2024-09-23
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

Order Status Remains Approved When Should Indicate Complete.

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