FDA-Device2021-10-06Class II

MOSAIQ Oncology Information System

Elekta, Inc.
Hazard

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

Sold states
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.
Affected count
31
Manufactured in
100 Mathilda Pl, 5th Floor, Sunnyvale, CA, United States
Products
MOSAIQ Oncology Information System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2021

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