Recall Z-0557-2016— Elekta, Inc.
Class II · Terminated
Class II FDA medical device recall by Elekta, Inc., initiated 2015-12-09, terminated 2022-09-27. It names one FDA 510(k) clearance: K141572. 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.. Reason: Incorrect drug dosage due to "Age Limit" and patient weight data item issue..
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-09
- Terminated
- 2022-09-27
- Firm location
- Atlanta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.