CLASS II ONGOING Device recall · Reported 3 Jul 2024 · FDA Enforcement Report
ZE for Vertix Solitaire - The Axiom Vertix Solitaire recalled
Siemens Medical Solutions USA is recalling ZE for Vertix Solitaire - The Axiom Vertix Solitaire is a component and has been, distributed nationwide in the US. The recall was initiated on 31 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2188-2024
- FDA event ID
- 94777
- Recalling firm
- Siemens Medical Solutions USA, Malvern, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 May 2024
- FDA classified
- 25 Jun 2024
- Reported
- 3 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 May 2024 | Recall initiated by company | |
| 25 Jun 2024 | Classified by FDA | +25 days |
| 3 Jul 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Which lots are affected?
UDI-DI: N/A Serial Numbers: 1239 1241
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 94777This product is part of a recall event; the main page for the event is Axiom Vertix MD - The Vertix MD Trauma has been specially recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Axiom Vertix MD - The Vertix MD Trauma has been specially recalled | Siemens Medical Solutions USA | Other | Nationwide | |
| CLASS II | Multix TOP recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide | |
| CLASS II | Axiom Multix MP - Inended Radiographic X ray Table recalled | Siemens Medical Solutions USA | Other | Nationwide | |
| CLASS II | Multix TOP recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide | |
| CLASS II | Axiom Multix MP - Intended Radiographic X ray Table recalled | Siemens Medical Solutions USA | Other | Nationwide | |
| CLASS II | Axiom Vertix Solitaire - The Vertix MD Trauma has been recalled | Siemens Medical Solutions USA | Other | Nationwide | |
| CLASS II | Axiom Multix MT - Intended Radiographic X ray Table recalled | Siemens Medical Solutions USA | Other | Nationwide | |
| CLASS II | Axiom Multix MT - Intended Radiographic X ray Table recalled | Siemens Medical Solutions USA | Other | Nationwide |
More recalls from Siemens Medical Solutions USA
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|---|---|---|---|---|---|
| Device | CLASS II | Artis icono ceiling recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono biplane recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono floor recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis icono ceiling recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
| Device | CLASS II | Artis pheno recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | PA |
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|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |