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Recall Observatory FDA recall evidence

Device product

Cios Alpha, mobile X-ray system

Z-1278-2016

February 19, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 73605
Status
Terminated
Classification
Class II
Quantity
89 systems
Official record key
device-enforcement:Z-1278-2016

Official wording

Reason: Software issues on Cios Alpha mobile C-Arm system

Code information: Model # 10308191

Distribution pattern: Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Software issues on Cios Alpha mobile C-Arm system