LIEBEL-FLARSHEIM COMPANY LLC recalls HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)

Recall date

March 11, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1992-2021

FDA classification

Class II

Brand / firm

LIEBEL-FLARSHEIM COMPANY LLC

Sold / distributed

US Nationwide Distribution and in the country of Canada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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