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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM Vertix MD

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 Class 2 Device Recall AXIOM Vertix MDsee related information
Date Initiated by FirmMay 31, 2024
Date PostedJune 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2184-2024
Recall Event ID 94777
Product Classification Table, radiographic, non-tilting, powered - Product Code IZZ
ProductAXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543
Code Information UDI-DI: N/A Serial Numbers: 1040 1020
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactSAME
610-219-4834
Manufacturer Reason
for Recall		Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
FDA Determined
Cause 2		Under Investigation by firm
ActionSiemens 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 in Commerce2 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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