Recall Z-1233-2023— Elekta Inc

Name: FDA recall Z-1233-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-28

Class II · Ongoing

Class II FDA medical device recall by Elekta Inc, initiated 2023-02-28. It names one FDA 510(k) clearance: K151233. Product: Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.. Reason: Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation..

Recalling firm: Elekta Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-02-28
Firm location: Saint Charles, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K151233 — MonacoImpac Medical Systems, Inc.·cleared 2015-07-07

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. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Reason for recall

Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.

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