# FDA recall Z-2833-2018

> **LIEBEL-FLARSHEIM COMPANY LLC** · Class II · device recall initiated 2017-02-27.

## Product

Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR)      Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.

## Reason for recall

Software issue.  The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%.  The display in all other modes deviated by less than 35% from the dosimeter readings.

## Distribution

US Distribution to: AL, AZ, CA, CT, CO, FL GA, HI,  IA, IL, ID,  KS, KY, MD, MI, Michigan, MN, NC, NH, NV, NY, OK, OH, PA, SC, TN, TX, VA,  WA, WI,  and WV,

## Key facts

- **Recall number:** Z-2833-2018
- **Recalling firm:** LIEBEL-FLARSHEIM COMPANY LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-02-27
- **Report date:** 2018-08-29
- **Termination date:** 2023-08-16

- **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-2833-2018

## Citation

> AI Analytics. FDA recall Z-2833-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2833-2018. Source: US FDA. Licensed CC0.

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