Z-2188-2024Class II

ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for...

Name: Z-2188-2024 ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for...
Creator: Siemens Medical Solutions USA, Inc
Published: 2024-05-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2024-05-31 / Open, Classified

FDA source

Siemens Medical Solutions USA, Inc began a recall of ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as... on 2024-05-31. FDA classified it as Class II and gives the reason as "Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2188-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-31
Posted: 2024-06-25
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Material Number: 5901900
Product code: IZZ Table, Radiographic, Non-Tilting, Powered
Reason for recall: Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
FDA 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 in commerce: 2 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: N/A Serial Numbers: 1239 1241

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2188-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2180-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-25
Z-2181-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-25
Z-2182-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-25
Z-2183-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-25
Z-2184-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-25
Z-2185-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-25
Z-2186-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-25
Z-2187-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-25
Z-2188-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-25

Product code IZZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)