Recall Z-2186-2024 ยท IZZ Table, Radiographic, Non-Tilting, Powered
Siemens Medical Solutions USA, Inc
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517
| 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 | 3 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971452 | MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE Siemens Medical Solutions USA, Inc., May 14, 1997 |