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Recall Observatory FDA recall evidence

Device product

MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440

Z-1859-2024

May 03, 2024

Class II

Product summary

Firm
Philips North America Llc
Event
Event 94508
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1859-2024

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: 70980, 71569

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