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