The Recall Desk
HighFDA (Devices)·Z-0854-2021·Announced 2021-01-20

GE Healthcare Recalls 12 NM/CT 860 Systems Due to Loose Rotor Bearing Screws

GE Healthcare is recalling 12 NM/CT 860 systems because loose rotor bearing screws caused a bearing 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 is classified as FDA Class II, and the source describes a mechanical defect (bearing release) that poses a risk of harm to the device or patient, but no injuries or illnesses are reported in the text.

Plain-English summary

GE Healthcare, LLC is recalling 12 units of the GE NM/CT 860 system (Model Number H3908AD). These systems are intended for general Nuclear Medicine imaging procedures to detect radioisotope tracer uptake in the patient body.

The recall was initiated after loose rotor bearing screws were found on one detector in the field. This condition led to the release of one of the four rotor bearings in that specific detector. The affected units were distributed worldwide.

Healthcare facilities should contact GE Healthcare for instructions on how to address the issue with the affected serial numbers. The specific serial numbers involved are: 860Y62016, 860Y62019, 860Y62017, 860Z62032, 860Y62018, 860Y62015, 860Y62012, 860Y62020, 860Y62021, 860Y62013, 860Z62033, and 860Z62031.

The recalled product

Product
GE NM/CT 860 system Model Number H3908AD - 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
12

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 (12)

  • Serial numbers: 860Y62016
  • 860Y62019
  • 860Y62017
  • 860Z62032
  • 860Y62018
  • 860Y62015
  • 860Y62012
  • 860Y62020
  • 860Y62021
  • 860Y62013
  • 860Z62033
  • 860Z62031

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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