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Recall Observatory FDA recall evidence

Device product

Discovery NM/CT 670 ES, model 5376204-70-57

Z-0607-2019

May 24, 2018

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 81680
Status
Completed
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0607-2019

Official wording

Reason: When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.

Code information: GTIN 00840682123877 Serial Numbers: ESDX35013, ESDW35010

Distribution pattern: CA, DC, OH, UT, WI, Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.