Reported May 8, 2019 · Terminated
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general…
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 830 Product UsageThe Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components
- of the Discovery NM 630 system areNM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console
- Lot codes and dates
- Mfg. Lot or Serial # System ID Model, Catalogue or Code #
111 of 111 codes
830Y60040256737NMH3910AC830X60004901227NM1H3910AC830X60001479338N830H3910AC830Y60036860496NM830H3910AC830X60018772468NM830H3910AC830X60026954721NMH3910AC830X60012813315D830H3910AC830Y60030813874D830H3910AC830X60011225761NM1H3910AC830X60016225761NMH3910AC830Y60029410554NMH3910AC830X60019573458NMH3910AC830X60027603742NM830H3910AC830X60014718238D830H3910AC830X60015585396NMH3910AC830X60006716862NM830H3910AC830Y60031631726D830H3910AC830X60003585786NM830H3910AC830X60021615316NM830H3910AC830Y60034936CMC830H3910AC
- Mfg. Lot or Serial # System ID Model, Catalogue or Code #
- Amount recalled
- 37 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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