Elekta, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2277-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.

Product Classification:

Class II

Date Initiated: May 22, 2013

Date Posted: October 2, 2013

Recall Number: Z-2277-2013

Event ID: 65998

Reason for Recall:

Patient needs to be positioned as indicated by the treatment plan.

Status: Terminated

Product Quantity: 72

Code Information:

All versions of Monaco

Distribution Pattern:

Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated