Recall Z-0855-2021— GE Healthcare, LLC

Name: FDA recall Z-0855-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-10

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2020-12-10. It names one FDA 510(k) clearance: K153402. Product: GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.. 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2020-12-10
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K153402 — Discovery NM/CT 670 CZTGE Healthcare·cleared 2016-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.