# FDA recall Z-1992-2021

> **LIEBEL-FLARSHEIM COMPANY LLC** · Class II · device recall initiated 2021-03-11.

## Product

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

## 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.

## Distribution

US Nationwide Distribution and in the country of Canada

## Key facts

- **Recall number:** Z-1992-2021
- **Recalling firm:** LIEBEL-FLARSHEIM COMPANY LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-11
- **Report date:** 2021-07-14
- **Termination date:** 2024-09-18

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Saint Louis, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1992-2021

## Citation

> AI Analytics. FDA recall Z-1992-2021. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-1992-2021. Source: US FDA. Licensed CC0.

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