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Leibel-Flarsheim Company LLC recalls Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imagi
Recalled July 24, 2013 · FDA recall Z-1753-2013 · Leibel-Flarsheim
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. · FDA Class II
Units
12 units
Sold at
Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.
Description
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.
Product
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Manufacturer(s)
Leibel-Flarsheim Company LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →