Recall Z-2526-2024 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
| Date | Aug 7, 2024 (initiated Jul 2, 2024) |
| Status | Open, Classified |
| Reason | The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays |
| Root cause | Under Investigation by firm |
| Action | Siemens issued Customer Safety Advisory Notice (CSAN) XP017/24/S to Director of Diagnostic Imaging and/ or Radiology Laboratory on 7/2/24. Letter states reason for recall, health risk and action to take: Please visually inspect the mounting screw on the ceiling tube (Figure 1) or wall tube (Figure 2) of the display suspension as far as this is possible from the floor. In case the visual inspection of the mounting screw does not show any abnormalities, you can continue to use the system. Nevertheless, until the system has been checked by Siemens Healthineers customer service with the planned fi |
| Quantity | 24 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax Siemens Medi Cal Solutions, Inc., Apr 2, 2018 |