FDA-Device2013-07-24Class II
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Leibel-Flarsheim Company LLC
Hazard
A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min.
Sold states
Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.
Affected count
12 units
Manufactured in
2111 E Galbraith Rd, N/A, Cincinnati, OH, United States
Products
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1753-2013Don't want to check this manually?
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