—#189270

Product

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

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K183037, K190178
Affected lot / code info: Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10; UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002190(10) 5.40.01, (01)00858164002190(10) 5.40.02, (01)00858164002268(10) 5.51.10

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

A Recall notification letter titled, "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" was sent to consignees on 09/14/2021 via email. The letter instructs the consignee of the following: "When using Monaco in offline mode, ensure that the active image set is selected in the workspace control when using the Auto Margin tool." The consignee is to post the notice in a place that is accessible to all users until the action is closed. Furthermore, the consignee is to advise the appropriate personnel, working with this product, on the content of the letter. The firm is requesting that the consignee submit an acknowledgement form as well via the Elekta Care" Community or complete the form and return it to Elekta immediately upon receipt, but no later than within 30 days.

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 PA, MI, WI, NY, TN, NJ, IA, TX and the countries of United Kingdom, Turkey, Switzerland, Sweden, Spain, Netherlands, Korea, Thailand, Japan, Italy, Hong Kong, Germany, France, Denmark, China, Canada, Belgium, Bahrain, Australia.

Timeline

Recall initiated: 2021-09-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189270. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.