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Recall Observatory FDA recall evidence

Device product

HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)

Z-1992-2021

March 11, 2021

Class II

Product summary

Firm
LIEBEL-FLARSHEIM COMPANY LLC
Event
Event 88195
Status
Terminated
Classification
Class II
Quantity
17
Official record key
device-enforcement:Z-1992-2021

Official wording

Reason: 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.

Code information: Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS

Distribution pattern: US Nationwide Distribution and in the country of Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.