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Recall Observatory FDA recall evidence

Device product

GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Z-0853-2021

December 10, 2020

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 87023
Status
Ongoing
Classification
Class II
Quantity
24 units
Official record key
device-enforcement:Z-0853-2021

Official wording

Reason: GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

Code information: Serial numbers: 85EY67048, 850Y61018, 85EY67045, 85EY67046, 85EY67047, 850Z61038, 85EY67043, 850Z61042, 85EZ67056, 850Z61043, 850Z61044, 850Z61045, 850Z61041, 850Z61039, 850Z61040, 85EZ67055, 85EZ67053, 85EZ67054, 850Y61019, 85EY67044, 85EY67049, 85EZ67052, 85EY67050, 85EZ67051

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.