FDA Device recall Z-1992-2021
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
- FDA Device
- Class II
- terminated
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) by Liebel Flarsheim, citing 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 val….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1992-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-11 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Liebel Flarsheim |
| Distribution | US |
Product
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Reason
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.
Identifiers
| code_info | Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1992-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.