—#171917

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K173816
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

GE Healthcare sent an Urgent Medical Device Correction letter dated March 20, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. GE Healthcare will inspect and, if required, correct all affected products at no cost to you to ensure that all design redundancies are in place. A GE Healthcare representative will contact you to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK

Timeline

Recall initiated: 2019-03-20
Terminated: 2020-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171917. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.