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: July 22, 2015 Initiated: July 1, 2015 #Z-2063-2015

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

A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.

Details

Recalling Firm
Elekta, Inc.
Units Affected
74 Total (45 US)
Distribution
Worldwide Distribution - US including AZ, CA, GA, ID, IL, MO, NJ, NY, NC, OR, SC, TN, WV, and Internationally to Austria, Brazil, Bulgaria, Canada, Colombia, Germany, Israel, Italy, Japan, Mexico, Russia, Taiwan, and Venezuela.
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: 74 Total (45 US).
Why was this product recalled?
A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 22, 2015. Severity: Moderate. Recall number: Z-2063-2015.