Recall – Treatment plan system may save changes to unintended target

Company: Elekta Inc.
Date of Enforcement Report: 10/6/2021
Class II

PRODUCT

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

Recall Number: Z-2563-2021

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/MANUFACTURER

Elekta Inc. on 9/14/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

214 units

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.