AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395431
FDA Recall Z-2183-2024 · Posted 2024-06-25
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeIZZ
Date Initiated2024-05-31
Product Quantity20 units
Reason for Recall
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
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 perform the replacement of the PSU of the Touch Display via UI
XP006/24/S beginning in the second quarter (June) of 2024. This replacement will be provided to you free of
charge. Based on our investigation you can continue to use your system following the recommendation to switch
off the system / Touch Display when it is not in use and is unattended.
Our service organization will contact you to arrange a date to perform this corrective action once it is available.
Please feel free to contact our Customer Care Center at 1-800-888-7436 for an earlier appointment beginning in June 2024.
Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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