The Recall Desk
HighFDA (Devices)·Z-0853-2021·Announced 2021-01-20

GE Healthcare Recalls NM/CT 850 Systems Due to Loose Rotor Bearing Screws

GE Healthcare is recalling 24 NM/CT 850 systems because loose rotor bearing screws caused a bearing to release in one field unit.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device (loose screws leading to bearing release) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

GE Healthcare, LLC is recalling 24 units of the GE NM/CT 850 system, Model Number H3907AD. These systems are intended for general Nuclear Medicine imaging procedures to detect radioisotope tracer uptake in the patient body. The affected units were distributed worldwide.

The recall was initiated because GE Healthcare became aware that rotor bearing screws were found loose on one detector in the field. This issue led to the release of one of the four rotor bearings in that specific detector. The source text does not report any patient injuries or illnesses associated with this defect.

Healthcare facilities should contact GE Healthcare for instructions on how to address the loose screws and ensure the integrity of the rotor bearings. The recall covers specific serial numbers listed in the agency's documentation.

The recalled product

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.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial numbers: 85EY67048
  • 850Y61018
  • 85EY67045
  • 85EY67046
  • 85EY67047
  • 850Z61038
  • 85EY67043
  • 850Z61042
  • 85EZ67056
  • 850Z61043
  • 850Z61044
  • 850Z61045
  • 850Z61041
  • 850Z61039
  • 850Z61040
  • 85EZ67055
  • 85EZ67053
  • 85EZ67054
  • 850Y61019
  • 85EY67044

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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