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Recall Observatory FDA recall evidence

Device product

AMX Navigate Mobile X-Ray System

Z-2590-2021

June 24, 2021

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 88601
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-2590-2021

Official wording

Reason: An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.

Code information: AMXNV2000001WK, AMXNV2000002WK, DF2401600003WK

Distribution pattern: Domestic Distribution Only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.