Recalls / —

—#178080

Product

Monaco Radiation Treatment Planning System (RTP) System

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, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00

Why it was recalled

Monaco is using the incorrect energy when optimizing and calculating dose.

Root cause (FDA determination)

Software Design Change

Action the firm took

An Important Field Safety Notification letter is being emailed to affected customers beginning 11/22/2019. The letter identifies affected product, provides a description of the problem, and recommends user not use multiple energies within the same plan until a software fix has been applied to the device. A response form was asked to be returned. Affected customers are advised to contact local Elekta service teams for questions.

Recalling firm

Firm

Elekta Inc

Address

1450 Beale St, Ste 205, Saint Charles, Missouri 63303

Distribution

Distribution pattern

IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.

Timeline

Recall initiated

2019-11-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #178080. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.