LIEBEL-FLARSHEIM COMPANY LLC: Medical Device Recall in 2021 - (Recall #: Z-1992-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 11, 2021

Date Posted: July 14, 2021

Recall Number: Z-1992-2021

Event ID: 88195

Reason for Recall:

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.

Status: Terminated

Product Quantity: 17

Code Information:

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

Distribution Pattern:

US Nationwide Distribution and in the country of Canada

Voluntary or Mandated:

FDA Mandated