Recall Z-0670-2020— Elekta Inc

Name: FDA recall Z-0670-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-22

Class II · Ongoing

Class II FDA medical device recall by Elekta Inc, initiated 2019-11-22. It names 2 FDA 510(k) clearances: K190178, K183037. Product: Monaco Radiation Treatment Planning System (RTP) System. Reason: Monaco is using the incorrect energy when optimizing and calculating dose..

Recalling firm: Elekta Inc
Classification: Class II
Status: Ongoing
Initiated: 2019-11-22
Firm location: Saint Charles, MO, United States

510(k) clearances named in this recall

2 on FDA's record

K190178 — Monaco RTP SystemElekta, Inc.·cleared 2019-03-29
K183037 — Monaco RTP SystemElekta, Inc.·cleared 2018-12-04

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

Monaco Radiation Treatment Planning System (RTP) System

Reason for recall

Monaco is using the incorrect energy when optimizing and calculating dose.

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