Recalls / —

—#115838

Product

Monaco RTP System. Radiation treatment planning.

FDA product code

MUJ — System, Planning, Radiation Therapy Treatment

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K110730

Affected lot / code info

Versions 3.20.00 and 3.20.01

Why it was recalled

The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice.

Recalling firm

Firm

Elekta, Inc.

Address

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

Distribution

Distribution pattern

Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.

Timeline

Recall initiated

2013-02-11

Posted by FDA

2013-02-20

Terminated

2014-01-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #115838. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.