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.
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.
The system may display a higher radiation dose than what is actually delivered to patients. This discrepancy could lead to unnecessary radiation exposure during medical imaging procedures, potentially increasing health risks for patients.
Medical facilities using the HydraVision Digital Imaging System with Product ID 705559 (65KW) or 705560 (80KW) are likely affected. Patients undergoing medical imaging procedures with these systems may be at risk of unnecessary radiation exposure.
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.
Identify the Product ID/Reorder Number on your HydraVision Digital Imaging System, which should be 705559 (65KW) or 705560 (80KW).
The model number is HUTSHVDIS.
The system may display a higher radiation dose than actually delivered, potentially leading to unnecessary radiation exposure for patients.
The recall record does not specify a remedy.
We’ve drafted a message you can send LIEBEL-FLARSHEIM to request your refund or repair — edit it as you like.
Subject: Recall Z-1992-2021 — LIEBEL-FLARSHEIM LIEBEL-FLARSHEIM Hello, I own a LIEBEL-FLARSHEIM that is covered by recall Z-1992-2021 from LIEBEL-FLARSHEIM. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
