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Recall Observatory FDA recall evidence

Device product

MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

Z-0221-2015

November 03, 2014

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 69656
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-0221-2015

Official wording

Reason: A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.

Code information: MOSAIQ Release 2.60.257

Distribution pattern: US Nationwide Distribution in the states of AZ. CO, IL, MD, MO, NY, OK, OR, PA, RI, TX, VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.