Elekta, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0557-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

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: December 9, 2015

Date Posted: January 6, 2016

Recall Number: Z-0557-2016

Event ID: 72801

Reason for Recall:

Incorrect drug dosage due to "Age Limit" and patient weight data item issue.

Status: Terminated

Product Quantity: 399

Code Information:

Versions 2.50 and higher

Distribution Pattern:

Worldwide Distribution: US (nationwide) including states of: AK, AZ, AR, CA, CO, CT, DE DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, ,MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WY; and countries of: Antiqua & Barbuda, Australia, Austria, Bahama, Bahrain, Canada, Czech Republic, Germany, Hungary, Saudi Arabia, Sweden, Turkey, & United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated