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Recall Observatory FDA recall evidence

Device product

MOSAIQ Oncology Information System

Z-2293-2016

July 15, 2016

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 74668
Status
Ongoing
Classification
Class II
Quantity
383
Official record key
device-enforcement:Z-2293-2016

Official wording

Reason: 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.

Code information: Versions 2.50.05 and higher

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.