HydraVision Imaging System (Liebel-Flarsheim) – Performance Standard Failure (2021)
Displayed radiation dosage may not accurately match the actual delivered dose.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Brand
LIEBEL-FLARSHEIM COMPANY LLC
Lot Codes / Batch Numbers
Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS
Products Sold
Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS
LIEBEL-FLARSHEIM COMPANY LLC is recalling HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) due to 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 no. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The product can be brought into compliance via a software update. The firm plan to have the updated software installed, working with customer schedules, over the course of the next 12 months.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026