FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399
- Recall number
- Z-2180-2024
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399
- Status
- Open, Classified
- Initiated
- 2024-05-31
- Posted
- 2024-06-25
- Terminated
- not on file
- 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 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.
- Quantity
- 50 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: N/A Serial Numbers: 1003 1032 1039 1060 1065 1071 1076 1082 1083 1085 1089 1092 1104 1170 1174 1181 1183 1194 1304 1305 1309 1310 1315 1318 1323 1325 1331 1348 1359 1382 1395 1398 1423 1443 1444 1447 1449 1452 1453 1468 1498 1500 1508 1509 1512 1513 1515 1516 1525 1531
- 510(k) numbers
- ["K971452"]
- PMA numbers
- not on file
- Product code
- IZZ
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28