—#148151

Product

MOSAIQ Oncology Information System

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123230
Affected lot / code info: Versions 2.50.05 and higher

Why it was recalled

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.

Root cause (FDA determination)

Software Design Change

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: Worldwide distribution. US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom

Timeline

Recall initiated: 2016-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148151. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.