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Recall Observatory FDA recall evidence

Device product

Ingenia Ambition X, Model No. 782109

Z-0810-2024

December 29, 2023

Class III

Product summary

Firm
Philips North America
Event
Event 93788
Status
Ongoing
Classification
Class III
Quantity
7 US; 16 ROW total
Official record key
device-enforcement:Z-0810-2024

Official wording

Reason: An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.

Code information: Model No. 782109 UDI-DI 00884838098350 Serial Number 47785

Distribution pattern: Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label is missing