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Recall Observatory FDA recall evidence

Device product

Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143

Z-1844-2024

May 03, 2024

Class II

Product summary

Firm
Philips North America Llc
Event
Event 94508
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1844-2024

Official wording

Reason: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information: UDI-DI: N/A Serial Numbers: 42246 85713 42029 71774 85668 85680 85685 85694 85705 42023 42024 42375 42217 42402 71044 85698 85700 85146 85677 85699 71595 71815 85649 42320 85684 71836 85679 85682 85697 85701 85708 85714

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire