Recall Z-1783-2021— Elekta, Inc.

Name: FDA recall Z-1783-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-20

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2021-04-20, terminated 2023-01-17. It names 2 FDA 510(k) clearances: K183034, K141572. Product: Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud. Reason: Malware attack.

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-04-20
Terminated: 2023-01-17
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

2 on FDA's record

K183034 — MOSAIQ Oncology Information SystemElekta, Inc.·cleared 2018-12-04
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

Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud

Reason for recall

Malware attack

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