Elekta, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1009-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Product Classification:

Class II

Date Initiated: December 21, 2016

Date Posted: January 18, 2017

Recall Number: Z-1009-2017

Event ID: 76028

Reason for Recall:

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

Status: Terminated

Product Quantity: 279

Code Information:

Software Versions 5.00 and higher

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

Voluntary or Mandated:

Voluntary: Firm initiated