Recall Z-3110-2017— Elekta, Inc.

Name: FDA recall Z-3110-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-30

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2017-06-30, terminated 2020-10-26. It names one FDA 510(k) clearance: K141572. Product: MOSAIQ Medical Charged-Particle Radiation Therapy System. Reason: The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-30
Terminated: 2020-10-26
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 Medical Charged-Particle Radiation Therapy System

Reason for recall

The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.

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