—#208271

Product

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 product code: IZZ — Table, Radiographic, Non-Tilting, Powered
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K971452
Affected lot / code info: UDI-DI: N/A Serial Numbers: 1004 1006 1051 1062 1172 1173 1175 1179 1180 1181 1184 1186 1187 1193 1198 1200 1202 1204 1205 1206

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-05-31
Posted by FDA: 2024-06-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208271. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.