Reported May 8, 2019 · Terminated
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- NM/CT 870 CZT, Model/Catalogue/Code #
- H3906CW Product UsageThe 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
- Lot codes and dates
- Mfg. Lot or Serial # System ID 87CY63017 SHIPPED (AO 1630621)
87CX63007AH0101NM0587CX63014030078NU2887CX63008190020NU0187CX63006030240NU1187CX63015705743NM87087CX63011M418487987CX63003M988687387CX63004X17158200387CX63009M17158201887CX63010UC1796NU0187CX63013NO1068MN1887CX63005A004NU2087CX63002C028NU0187CX63012C028NU0287CX63001900010NU12
- Mfg. Lot or Serial # System ID 87CY63017 SHIPPED (AO 1630621)
- Amount recalled
- 16 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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