Recall Z-0856-2021— GE Healthcare, LLC

Name: FDA recall Z-0856-2021
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: K111445. Product: Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - 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

K111445 — DISCOVERY NM 630GE Healthcare·cleared 2011-06-03

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

Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - 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.