LIEBEL-FLARSHEIM COMPANY LLC Recall 88195
Description: HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
LIEBEL-FLARSHEIM COMPANY LLC Recall 88195 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-1992-2021 |
| Event ID | 88195 |
| Event Description | HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) |
| Product Type | Devices |
| Distribution | US Nationwide Distribution and in the country of Canada |
| Quantity | 17 |
| Recall 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. |
| Device Classification | 20210714 |
| Device Code Info | Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS |
| Center Classification Date | 20210702 |
| Recall Initiation Date | 20210311 |
| Recalling Firm | LIEBEL-FLARSHEIM COMPANY LLC |
| Initial Notification | Letter |
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