Recall Z-2063-2015 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
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.
| Date | Jul 14, 2015 (initiated Jul 1, 2015) |
| Status | Terminated |
| Reason | A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones. |
| Root cause | Software design |
| Action | Elekta sent an Urgent Important Field Safety Notice 371-01-MSQ-003 on July 1, 2015, to all affected customers. The notice informed users of the specific product and version numbers affected and that the problem only exists if all the following criteria is met - (1) Running Mosaiq 2.41; (2) with at least one linac equipped with an Agility 160 MLC head (Versa HD, Infinity, Axesse (EOS) or Synergy); and (3) who are treating with Stereotactic Cones. The notice also advises users of the workaround to avoid the problem. The customers were also instructed to return the Important Field Safety Notic |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Sep 5, 2014 |