Elekta, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1244-2015)

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:

Focal Sim radiation therapy treatment planning system

Product Classification:

Class II

Date Initiated: December 19, 2014

Date Posted: March 11, 2015

Recall Number: Z-1244-2015

Event ID: 70433

Reason for Recall:

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

Status: Terminated

Product Quantity: 907

Code Information:

Focal Release 4.80

Distribution Pattern:

Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulgaria, Bahrain, Brazil, Belarus, Canada, Chile, China, Colombia, Cuba, Cyprus, Czech Republic, Germany, Algeria, Egypt, Spain, France, Great Britain, Greece, Croatia, Indonesia, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Sri Lanka, Lithuania, Libya, Morocco, Macedonia, Mexico, Malaysia, New Zealand, Philippines, Portugal, Romania, Serbia, Russia, Singapore, Slovenia, Suriname, Thailand, Turkey, Ukraine, Venezuela, South Africa, Kosovo.

Voluntary or Mandated:

Voluntary: Firm initiated