Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Company
- Elekta Inc
- Recall Initiated
- September 14, 2021
- Recall Number
- Z-2563-2021
- Quantity
- 214 units
- Firm Location
- Saint Charles, MO
Reason for Recall
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.
Distribution
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.
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
Root Cause
Software design
Action Taken
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.