FDAFDA · Food and drugs·Recall number Z-2293-2016
MOSAIQ Oncology Information System
Published August 3, 2016 · Recall initiated: July 15, 2016
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- 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
- Versions 2.50.05 and higher
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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