Liebel-Flarsheim Hydra Vision Urology X-Ray System — Class II medical device recall Z-2833-2018
Terminated recall by LIEBEL-FLARSHEIM COMPANY LLC, reported 2018-08-29, distributed in AL, AZ, CA, CO, CT, FL, GA, HI…. Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exp
| Recall number | Z-2833-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | LIEBEL-FLARSHEIM COMPANY LLC, Saint Louis, MO, United States |
| Recall initiated | 2017-02-27 |
| Classified | 2018-08-21 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2023-08-16 |
| Distributed | AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, MI, MN, NC, NH, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV |
| Quantity | 313 |
| Reason classes | software |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2833-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.