Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0557-2016

December 09, 2015

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 72801
Status
Terminated
Classification
Class II
Quantity
399
Official record key
device-enforcement:Z-0557-2016

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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