GE Healthcare, LLC: Medical Device Recall in 2021 - (Recall #: Z-0857-2021)

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:

Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

Product Classification:

Class II

Date Initiated: December 10, 2020

Date Posted: January 20, 2021

Recall Number: Z-0857-2021

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: 52 untits

Code Information:

Discovery 670 DR (Model H3100BT), Serial Numbers: DRGY56033, DRGY56037, DRGY56035, DRGY56030, DRGZ56043, DRGZ56042, DRGY56032, DRGY56031, DRGY56034, DRGY56036 NM/CT 870 DR (Model 3100Q), Serial Numbers: 870Y64066, and (Model H3100AS), Serial Numbers: 870Y64077, 870Y64064, 870Y64081, 870Y64079, 870Y64067, 870Y64074, 870Z64117, 870Y64078, 870Y64080, 870Y64069, 870Y64085, 870Z64121, 870Z64119, 870Z64122, 870Y64056, 870Y64063, 870Z64114, 870Z64115, 870Y64068, 870Y64082, 870Z64116, 870Z64120, 870Y64065, 870Y64084, 870Y64061, 870Y64083, 870Z64113, 870Y64070, 870Z64123, 870Y64058, 870Z64118, 870Y64057 Discovery NM670 Pro (Model 3100XB), Serial Numbers: PRGY52027, PRGY52031, PRGZ52047, PRGZ52046, PRGY52028, PRGZ52048, PRGY52029, PRGY52030 Discovery 670 ES (Model H3100XF), Serial Numbers: ESGZ53005

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated