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Recall Observatory FDA recall evidence

Device product

Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

Z-1750-2019

February 12, 2019

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 82982
Status
Ongoing
Classification
Class II
Quantity
1113 in total
Official record key
device-enforcement:Z-1750-2019

Official wording

Reason: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

Code information: Discovery Ml DR

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure