Recall Z-2406-2021— Elekta Inc

Name: FDA recall Z-2406-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-26

Class II · Ongoing

Class II FDA medical device recall by Elekta Inc, initiated 2021-07-26. It names 2 FDA 510(k) clearances: K190178, K183037. Product: Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10. Reason: If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams..

Recalling firm: Elekta Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-07-26
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 RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Reason for recall

If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

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