Recall Z-2833-2018 ยท IXR Table, Radiographic, Tilting
LIEBEL-FLARSHEIM COMPANY LLC
Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.
| Date | Feb 27, 2017 |
| Status | Terminated |
| Reason | Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | The firm, Liebel-Flarsheim, notified its customers by phone on or about 2/27/2017 to inform them of the product, problem and actions to be taken. The firm plans to have these Sedecal software updates implemented over the course of the next 12 months. For additional information, please contact me at 314-376-4788. |
| Quantity | 313 |
| Distribution | US Distribution to: AL, AZ, CA, CT, CO, FL GA, HI, IA, IL, ID, KS, KY, MD, MI, Michigan, MN, NC, NH, NV, NY, OK, OH, PA, SC, TN, TX, VA, WA, WI, and WV, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943581 | HYDRADJUST IV UROLOGICAL TABLE Mallinckrodt Group, Inc., Jan 4, 1995 |