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Recall Observatory FDA recall evidence

Device product

ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

Z-2524-2018

May 30, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 80417
Status
Terminated
Classification
Class II
Quantity
40 in the United States
Official record key
device-enforcement:Z-2524-2018

Official wording

Reason: During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).

Code information: 164033, 164071, 164034, 164095, 164057, 164054, 164055, 164080, 164072, 164088, 164048, 164094, 164068, 164019, 164013, 164073, 164025, 164026, 164027, 164060, 164083, 164021, 164066, 164075, 164074, 164084, 164086, 164098, 164028, 164053, 164063, 164064, 164024, 164049, 164018, 164022, 164061, 164100, 164097, 164011

Distribution pattern: The devices were distributed to the following US states: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).