HydraVision Digital Imaging System Product ID/Reorder Number: 705559 — Class II medical device recall Z-1992-2021
Terminated recall by LIEBEL-FLARSHEIM COMPANY LLC, reported 2021-07-14, distributed nationwide. Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the display
| Recall number | Z-1992-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | LIEBEL-FLARSHEIM COMPANY LLC, Saint Louis, MO, United States |
| Recall initiated | 2021-03-11 |
| Classified | 2021-07-02 |
| Reported by FDA | 2021-07-14 |
| Terminated | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 17 |
Product
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1992-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.