Recall Z-1753-2013 ยท OWB Interventional Fluoroscopic X-Ray System
Leibel-Flarsheim Company LLC
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
| Date | Jul 18, 2013 (initiated Apr 25, 2013) |
| Status | Terminated |
| Reason | A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min. |
| Root cause | Employee error |
| Action | The customers received an "Urgent Device Correction" notification letter on May 12, 2013 explaining the product issue and providing recommended actions. Customers were contacted to set up a service call to test and recalibrate equipment as necessary. Questions were directed to 800-778-7898. |
| Quantity | 12 units |
| Distribution | Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943581 | HYDRADJUST IV UROLOGICAL TABLE Mallinckrodt Group, Inc., Jan 4, 1995 |