FDA-Device2021-07-14Class II
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
LIEBEL-FLARSHEIM COMPANY LLC
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.
Sold states
US Nationwide Distribution and in the country of Canada
Affected count
17
Manufactured in
1034 S Brentwood Blvd, Saint Louis, MO, United States
Products
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1992-2021Don't want to check this manually?
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