medical Class II Updated 2021-07-14

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

Distribution: Nationwide (United States)
Lot/Code Info: Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS
View official government recall

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