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Recall Observatory FDA recall evidence

Device 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

Z-2188-2024

May 31, 2024

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 94777
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-2188-2024

Official wording

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

Code information: UDI-DI: N/A Serial Numbers: 1239 1241

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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