Lower riskMedical device recall · FDA · Published March 11, 2021
HydraVision Digital Imaging System: Incorrect Dose Display Risk
LIEBEL-FLARSHEIM recalls HydraVision Digital Imaging Systems with Product ID 705559 (65KW) and 705560 (80KW) due to potential overestimation of radiation dose. This may lead to unnecessary radiation exposure during medical procedures.
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.
Take action
Contact the company
📍Recalling firmLIEBEL-FLARSHEIM COMPANY LLC1034 S Brentwood Blvd · Saint Louis, MO 63117-1223
✎ GovInfoNow plain-language explainer
LIEBEL-FLARSHEIM is recalling HydraVision Digital Imaging Systems with specific product IDs because they may display a higher radiation dose than actually delivered. This could result in unnecessary radiation exposure for patients during medical imaging procedures. Read more at govinfonow.com/recall/63100-hydravision-digital-imaging-system-incorrect-dose-display-risk.
“HydraVision Digital Imaging System: Incorrect Dose Display Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63100-hydravision-digital-imaging-system-incorrect-dose-display-risk. Based on FDA recall #Z-1992-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1992-2021%22&limit=1).
The FDA announced on March 11, 2021, that Liebel-Flarsheim Company LLC is recalling the HydraVision Digital Imaging System because the displayed dosage is higher than the actual delivered dose. The agency issued this Class II recall under number Z-1992-2021.
How to tell if you have it
Brand: LIEBEL-FLARSHEIM
Product: HydraVision Digital Imaging System
Product ID/Reorder Number: 705559 (65KW)
Product ID/Reorder Number: 705560 (80KW)
Model/NDC: HUTSHVDIS
The hazard
The recall addresses a failure to comply with the performance standard for fluoroscopy systems, specifically that the displayed air kerma deviates from actual values by more than 35 percent. This results in the dosage displayed on the generator console and table monitor being higher than the actual delivered dose.
Context
GovInfoNow's records show Liebel-Flarsheim Company LLC has 1 other recall on record since 2026-07-31, specifically the Optiray Imaging Bulk Package-350 Recall for particulate matter hazard. Other recent recalls of similar products include Siemens ARTIS pheno X-ray System Recalled: Zero Dose Display Risk (2026-03-09), RayStation/RayPlan Software 11A Recalls: Radiation Dose Calculation Risk (2025-11-28), and Siemens ARTIS Pheno VE30A/VE40A: Risk of inaccurate 3D scans due to radiation exposure (2026-03-12).
How to tell if you have this one
Check for Product ID/Reorder Number 705559 (65KW) or 705560 (80KW) on the HydraVision Digital Imaging System. These models were sold with the model number HUTSHVDIS.
Brand
LIEBEL-FLARSHEIM
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product ID
Identify the Product ID/Reorder Number on your HydraVision Digital Imaging System, which should be 705559 (65KW) or 705560 (80KW).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution and in the country of Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1992-2021 (March 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1992-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.