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LIEBEL-FLARSHEIM COMPANY LLC recalls HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Recalled July 14, 2021 · FDA recall Z-1992-2021 · LIEBEL-FLARSHEIM
Hazard
Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ¿ 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose. · FDA Class II
Units
17
Sold at
US Nationwide Distribution and in the country of Canada
Description
Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ¿ 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
Product
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Manufacturer(s)
LIEBEL-FLARSHEIM COMPANY LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →