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Elekta, Inc. Recall 88599

Description: MOSAIQ Oncology Information System

Elekta, Inc. Recall 88599 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2591-2021
Event ID88599
Event DescriptionMOSAIQ Oncology Information System
Product TypeDevices
DistributionDistribution 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.
Recall ReasonA drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
Device Classification20211006
Device Code InfoMOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)
Center Classification Date20210929
Recall Initiation Date20210902
Recalling FirmElekta, Inc.
Initial Notification Letter
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