Recall Z-1258-2019— GE Healthcare, LLC

Name: FDA recall Z-1258-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-20

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-03-20, terminated 2020-10-05. It names one FDA 510(k) clearance: K153402. Product: Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.. Reason: During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-03-20
Terminated: 2020-10-05
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

Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Reason for recall

During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.

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