Recall Z-2188-2024 ยท IZZ Table, Radiographic, Non-Tilting, Powered
Siemens Medical Solutions USA, Inc
ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Material Number: 5901900
| Date | Jun 25, 2024 (initiated May 31, 2024) |
| Status | Open, Classified |
| Reason | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| Root cause | Under Investigation by firm |
| Action | Siemens issued Urgent Medical Device Correction Letter (XP008/24/S) to the Attention: Director of Diagnostic Imaging and/ or Radiology Laboratory on 5/31/24. Letter states reason for recall, health risk, and action to take: What steps can the user take to avoid the possible risks associated with this issue? It is recommended to switch off the system / Touch Display when it is not in use and is unattended. How will the issue be resolved? To ensure continued safe operation of your system and to provide safeguards for the life of the system, the Siemens Healthineers Service Organization will per |
| Quantity | 2 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.