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Recall Observatory FDA recall evidence

Device product

Siemens AXIOM Artis zeego x-ray, angiographic system

Z-1945-2013

May 13, 2013

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 65721
Status
Terminated
Classification
Class II
Quantity
132
Official record key
device-enforcement:Z-1945-2013

Official wording

Reason: Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system.

Code information: Model number 10280959

Distribution pattern: Nationwide distribution: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MD, MN, MO,MS, NC, NE, NH, NJ, NY, OH, PA, PR, SD, TN, TX, UT, VA, WA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system.