PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 6, 2016 Initiated: December 9, 2015 #Z-0557-2016

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.

Reason for Recall

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

Details

Recalling Firm
Elekta, Inc.
Units Affected
399
Distribution
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.
Location
Atlanta, GA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Elekta, Inc.. Units affected: 399.
Why was this product recalled?
Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 6, 2016. Severity: Moderate. Recall number: Z-0557-2016.