AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO a

FDA device recall Z-2182-2024 · posted 2024-06-25 · Open, Classified

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

Action taken

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

Status

Open, Classified

Product code

IZZ

Quantity affected

12 units

Distribution

US Nationwide distribution.

Date initiated

2024-05-31

Date posted

2024-06-25

Location

Malvern, PA

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