Elekta, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2063-2015)

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:

MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

Product Classification:

Class II

Date Initiated: July 1, 2015

Date Posted: July 22, 2015

Recall Number: Z-2063-2015

Event ID: 71573

Reason for Recall:

A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.

Status: Terminated

Product Quantity: 74 Total (45 US)

Code Information:

Software Version 2.41 and higher

Distribution Pattern:

Worldwide Distribution - US including AZ, CA, GA, ID, IL, MO, NJ, NY, NC, OR, SC, TN, WV, and Internationally to Austria, Brazil, Bulgaria, Canada, Colombia, Germany, Israel, Italy, Japan, Mexico, Russia, Taiwan, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated