FDA-Device2018-11-21Class II
RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
Virtual Imaging, Inc.
Hazard
There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the Tube Head Mount and potentially fall off the system.
Sold states
Worldwide Distribution - US Nationwide and the countries of, Canada, Italy
Affected count
253 units
Manufactured in
720 S Powerline Rd Ste E, Deerfield Beach, FL, United States
Products
RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0460-2019Don't want to check this manually?
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