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Recall Observatory FDA recall evidence

Device product

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Z-0127-2021

September 08, 2020

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 86452
Status
Terminated
Classification
Class II
Quantity
30 devices total
Official record key
device-enforcement:Z-0127-2021

Official wording

Reason: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Code information: Model: 5741000 and 5741000-20

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.