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Recall Observatory FDA recall evidence

Device product

Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical

Z-1391-2018

January 12, 2018

Class II

Product summary

Firm
NeuroLogica Corporation
Event
Event 79628
Status
Terminated
Classification
Class II
Quantity
16 units
Official record key
device-enforcement:Z-1391-2018

Official wording

Reason: While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.

Code information: Model Number GMR40. Serial numbers 00001 through 00016.

Distribution pattern: US Distribution . Only one consignee was shipped 16 units of the affected device.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.