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Recall Observatory FDA recall evidence

Device product

MOSAIQ Oncology Information System

Z-2917-2018

August 03, 2018

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 80764
Status
Terminated
Classification
Class II
Quantity
185
Official record key
device-enforcement:Z-2917-2018

Official wording

Reason: Order Status Remains Approved When Should Indicate Complete.

Code information: Software Build(s) 2.64 SP3 and higher

Distribution pattern: AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, WA, WI, WV, and WY Australia, Canada, Ireland, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, and United Kingdom

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Order Status Remains Approved When Should Indicate Complete.