Elekta, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1237-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Monaco radiation therapy treatment planning system. 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: December 19, 2014

Date Posted: March 11, 2015

Recall Number: Z-1237-2015

Event ID: 70434

Reason for Recall:

Incorrect CT to ED when using the Monaco Image Statistics Tool.

Status: Terminated

Product Quantity: 1354

Code Information:

Monaco Release 3.30 and higher

Distribution Pattern:

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AK, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and WI., and to the countries of Angola, Argentina, Austria, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Algeria, Ecuador, Spain, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Kazakhstan, Sri Lanka, Lithuania, Libya, Morocco, Myanmar, Malta, Mexico, Malaysia, Namibia, Nicaragua, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, Venezuela and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated