The Recall Desk
HighFDA (Devices)·Z-1992-2021·Announced 2021-07-14

HydraVision Fluoroscopy System Displays Inaccurate Radiation Dose Measurements

LIEBEL-FLARSHEIM is recalling HydraVision Digital Imaging Systems because the displayed radiation doses are higher than actual delivered doses, potentially affecting clinical decision-making and radiation safety.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a risk-of-harm medical device (fluoroscopy system) with a documented federal performance standard violation. No injuries or hospitalizations have been reported in the source material. The inaccuracy in radiation dose display creates potential for patient harm but falls short of the criteria for Severe classification.

Plain-English summary

LIEBEL-FLARSHEIM COMPANY LLC is recalling the HydraVision Digital Imaging System (Product ID/Reorder Numbers 705559 and 705560) due to inaccurate radiation dose measurement and display. The system's generator console and table display monitor show radiation doses that exceed the actual doses being delivered during imaging procedures.

The displayed Air Kerma Rate (AKR) and cumulative air kerma values deviate from actual values by more than the 35 percent tolerance permitted by federal fluoroscopy performance standards (21 CFR 1020.32(k)(6)). This inaccuracy in dose display could affect clinical decision-making and radiation safety monitoring during imaging procedures.

The recalled systems were distributed nationwide in the United States and in Canada. Approximately 17 units are subject to this recall. Healthcare facilities and imaging centers using these systems may be affected.

Users should contact LIEBEL-FLARSHEIM COMPANY LLC for corrective action. Immediate attention is recommended to ensure accurate dose monitoring and patient safety during fluoroscopy procedures.

The recalled product

Product
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Manufacturer
LIEBEL-FLARSHEIM COMPANY LLC
Category
Medical Device — Fluoroscopy / Medical Imaging
Hazard
  • radiation-dose-inaccuracy
  • dose-measurement-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category