Elekta, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0660-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 3, 2016

Date Posted: December 7, 2016

Recall Number: Z-0660-2017

Event ID: 75664

Reason for Recall:

Incorrect Dose when using the reset function.

Status: Terminated

Product Quantity: 671

Code Information:

Software Builds 5.11 and 5.20

Distribution Pattern:

AK, AZ, CA, CO, FL, GA, IL, IN, MA, MI, MN, MO, NV, NH, NY, NC, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Algeria, Australia, Austria, Brazil, Canada, China, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Laos, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela,

Voluntary or Mandated:

Voluntary: Firm initiated