medical Class II Updated 2018-07-04

Siemens Medical Solutions USA, Inc recalls ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model

Recalled Product

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

Hazard / Issue

If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.

Issued by

FDA

Affected States: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, VA

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

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