medical Class II Updated 2019-05-08

GE Healthcare, LLC recalls NM/CT 860 Product Usage: The GE NM/CT 860 system is

Recalled Product

NM/CT 860 Product Usage: The GE NM/CT 860 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 and vascular X-ray Computed Tomography applications.

Hazard / Issue

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.

Issued by

FDA

Distribution: US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
Lot/Code Info: Mfg. Lot or Serial # System ID Model, Catalogue or Code # 860Y62005 SHIPPED (GON 4736850) H3908AD 850X61003 401793860NM H3908AD 860X62001 E6843969 H3908AE 870X64005 HC4387NU05 H3100AS 860Y62004 083026212959219 H3908AD 860X62002 PL0399NM01 H3908AD
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Related medical Recalls

Boston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Cathete

2022-08-31 · The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

Mckesson Medical-Surgical Inc. Corporate Office recalls MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, w

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

GE Healthcare, LLC recalls (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (

2022-08-31 · Inaccurate Distance and Area measurements with use of Global Stack viewport.

Mckesson Medical-Surgical Inc. Corporate Office recalls B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY,

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.