Recall Z-2563-2021— Elekta Inc

Name: FDA recall Z-2563-2021
Creator: U.S. Food and Drug Administration
Published: 2021-09-14

Class II · Ongoing

Class II FDA medical device recall by Elekta Inc, initiated 2021-09-14. It names 2 FDA 510(k) clearances: K190178, K183037. Product: Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.. Reason: Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set..

Recalling firm: Elekta Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-09-14
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

Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Reason for recall

Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.

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