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Recall Observatory FDA recall evidence

Device product

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

Z-0131-2021

September 08, 2020

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 86452
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0131-2021

Official wording

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

Code information: Model: 5726207-8 and 5741000-28

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.