FDA recall Z-2917-2018

Elekta, Inc. · Class II · device

Product

MOSAIQ Oncology Information System

Reason for recall

Order Status Remains Approved When Should Indicate Complete.

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-08-03
Report date
2018-08-29
Termination date
2024-09-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2917-2018