—#188703

Product

Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

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: (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

If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Elekta will send an Important Field Safety Notice 382-01-MON-019 to all affected customers beginning August 10, 2021. The notice informs users of the specific product and version numbers affected by the issue, and any workaround that can be used to avoid the issue. A copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. Customers are asked to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible, but no later than 30 days after receipt. This issue is expected to be addressed in a future Monaco release, tentatively scheduled for the end of June 2022.

Recalling firm

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

Distribution

Distribution pattern: Distribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom

Timeline

Recall initiated: 2021-07-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188703. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.