Reported Jul 14, 2021 · Terminated
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Liebel-Flarsheim Company LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LIEBEL-FLARSHEIM COMPANY LLC · 1034 S Brentwood Blvd · Saint Louis, MO · 63117-1223
Is this the product you have?
- HydraVision Digital Imaging
- System Product ID/Reorder Number705559 (65KW)
- Lot codes and dates
- Product ID/Reorder Number
705559 (65KW)705560 (80KW)
- Model/NDCHUTSHVDIS
- Product ID/Reorder Number
- Amount recalled
- 17
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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