HydraVision Digital Imaging System Product ID/Reorder recall
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Why was HydraVision Digital Imaging System Product ID/Reorder 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS
- Product
- HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
- Recalling firm
- LIEBEL-FLARSHEIM COMPANY LLC
- Quantity
- 17
- Distribution
- US Nationwide Distribution and in the country of Canada
- Recall date
- July 14, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)