—#176158

Product

Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review

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

Why it was recalled

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

Root cause (FDA determination)

Software design

Action the firm took

The firm notified their consignees of the issue by email on 09/04/2019. The letter explained the problem and the workaround and requested the notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and that all appropriate personnel working with the product be advised of the content of the letter.

Recalling firm

Firm: Elekta Inc
Address: 13723 Riverport Dr, Ste 100, Maryland Heights, Missouri 63043-4819

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK

Timeline

Recall initiated: 2019-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176158. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.