—#151971

Product

Monaco RTP System Product Usage: 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: K132971, K151233
Affected lot / code info: Software Versions 5.00 and higher

Why it was recalled

Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Elekta sent an Urgent Important Field Safety Notification letter dated December 2016 to customers. The notice informs users of the specific product and version numbers affected by the issue and any work arounds that can be used to avoid the issue. The notice included a reply form to be returned to Elekta.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the state of CA, IN, KY, MA, NJ, NY, NC, PA, TX, WI, and the countries of Brazil, Canada, China, Croatia, Estonia, Germany, India, Japan, Netherlands, New Zealand, Norway, Poland, Serbia, South Africa, Spain, Russia, Turkey

Timeline

Recall initiated: 2016-12-21
Terminated: 2021-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.