ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Reported: August 1, 2018 Initiated: May 30, 2018 #Z-2524-2018
Product Description
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Reason for Recall
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 ).
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 40 in the United States
- Distribution
- 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.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 40 in the United States.
Why was this product recalled? ▼
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 ).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2018. Severity: Moderate. Recall number: Z-2524-2018.
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