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Recall Observatory FDA recall evidence

Device product

MOSAIQ Oncology Information System

Z-2591-2021

September 02, 2021

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 88599
Status
Ongoing
Classification
Class II
Quantity
31
Official record key
device-enforcement:Z-2591-2021

Official wording

Reason: A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.

Code information: MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)

Distribution pattern: Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.