LIEBEL-FLARSHEIM COMPANY LLC recalls HydraVision Digital Imaging System Product ID/Reorder Numbe
Recalled Product
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Hazard / Issue
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.
Issued by
FDA
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