GE Healthcare, LLC: Medical Device Recall in 2021 - (Recall #: Z-0858-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Product Classification:

Class II

Date Initiated: December 10, 2020

Date Posted: January 20, 2021

Recall Number: Z-0858-2021

Event ID: 87023

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 7 units

Code Information:

Serial Numbers: 64GY51017, 64GY51020, 64GY51022, 64GZ51028, 64GZ51030, 64GZ51029, 64GY51021

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated