Recall Z-1992-2021 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
LIEBEL-FLARSHEIM COMPANY LLC
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
| Date | Mar 11, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | The product can be brought into compliance via a software update. The firm plan to have the updated software installed, working with customer schedules, over the course of the next 12 months. |
| Quantity | 17 |
| Distribution | US Nationwide Distribution and in the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121838 | LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM Liebel-Flarsheim, Jul 11, 2012 |