medical Class II Updated 2018-08-01

Siemens Medical Solutions USA, Inc recalls ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 1084900

Recalled Product

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


Hazard / Issue

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 ).

Issued by

FDA

Affected States: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, VA
Lot/Code Info: 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
View official government recall

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