Recalls / —

—#140993

Product

Monaco - Radiation Treatment Planning 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

K151233

Affected lot / code info

Software Version 5.10.01

Why it was recalled

Unintended update of Dose and MU and Incorrect Assignment of Bolus.

Root cause (FDA determination)

Other

Action the firm took

Elekta sent Important Field Safety Notice 382-01-MON-003 to all customers on 10/16/2015. The notice informs users of the specific product and version numbers affected by both issues. The affected devices for both issues are those running Monaco 5.10.01. Customers are instructed to complete and return acknowledgement form. Solution/fix has been released in Monaco patch 5.10.02 and all affected users will be made aware of its availability by the end of October 2015.

Recalling firm

Firm

Elekta, Inc.

Address

400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern

CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom

Timeline

Recall initiated

2015-10-16

Posted by FDA

2015-10-30

Terminated

2017-04-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #140993. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.