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Recall Observatory FDA recall evidence

Device 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.

Z-1263-2019

March 20, 2019

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 82582
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-1263-2019

Official wording

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.

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.