MOSAIQ Oncology Information System
This recall is currently active, issued July 15, 2016. It was issued by Elekta, Inc..
- Company
- Elekta, Inc.
- Recall Initiated
- July 15, 2016
- Recall Number
- Z-2293-2016
- Quantity
- 383
- Firm Location
- Atlanta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.
Distribution
Worldwide distribution. US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom
Lot / Code Info
Versions 2.50.05 and higher
Root Cause
Software Design Change
Action Taken
Elekta sent Important Field Safety Notice 371-03-MSQ-001 to all customers on 7/15/2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. The letter also included a response form which is to be returned to Elekta.