Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2581-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.

Product Classification:

Class II

Date Initiated: August 18, 2014

Date Posted: September 10, 2014

Recall Number: Z-2581-2014

Event ID: 68985

Reason for Recall:

Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.

Status: Terminated

Product Quantity: 928 units

Code Information:

Versions 3.20.00 and higher

Distribution Pattern:

Worldwide distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, FL, IL, IN, MD, MA, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, Puerto Rico; and countries of: Algeria, Angola, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sir Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Ukraine.

Voluntary or Mandated:

Voluntary: Firm initiated