Recall record at a glance
| Official record | Z-1992-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | LIEBEL-FLARSHEIM COMPANY LLC |
| Report date | Jul 14, 2021 |
| Recall initiation date | Mar 11, 2021 |
| Quantity | 17 |
| Location | Saint Louis, MO, United States |
Official product description
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Why the product 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.
Distribution information
US Nationwide Distribution and in the country of Canada
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: FDA Mandated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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