—#181065

Product

Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K183037
Affected lot / code info: Software Build: 5.40.00 (UDI: (01)00858164002190(10) 5.40.00), 5.40.01 (UDI: 01)00858164002190(10) 5.40.01)

Why it was recalled

The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.

Root cause (FDA determination)

Software design

Action the firm took

In April of 2020, Elekta Inc. prepared an Urgent/Important Field Safety Notice identifying this issue, the actions that should be taken by the user/customer in order to prevent risks for patients and/or users, and the actions planned by Elekta to correct the problem. PRODUCT: The Monaco RTP System with versions 5.40 or 5.40.01 installed in or after June of 2018. ACTIONS TO BE TAKEN BY THE CUSTOMER OR USER: Customers/users are instructed to follow their standard clinical practice of reviewing plans, including the review of contours and volumes. DVHs that show unexpected overdose or under-dose should be investigated by the customer/user. The customer/user should post the issued notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and to advise the appropriate personnel who are working with this product on the content of this letter. Customers/users are also required to either acknowledge receipt of this notification via the Elekta Care Community or complete the provided acknowledgement form and return it to Elekta immediately upon receipt, but no later than within 30 days of receiving the notification letter.

Recalling firm

Firm: Elekta Inc
Address: 1450 Beale St, Ste 205, Saint Charles, Missouri 63303

Distribution

Distribution pattern: Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom.

Timeline

Recall initiated: 2020-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181065. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.