Reported May 8, 2019 · Terminated
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended…
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?
- Discovery NM 630 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 #SHIPPED (GON 4722927)
73 of 73 codes
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
SHIPPED (GON 4561460)H3101RH63GX50061702962NM1H3101RH63GX50035702962NM25376204-3163GX50050702388DISCH3101RH63GX50062702724DISCNMH3101RH63GX50032513861NMH3101RH63GX50055513861NM1H3101RH63GX50013740MGD630H3101RH63GX50047440743D630H3101RH63GX50002419251NMH3101RH63GX50025330841DISCNMH3101RH63GX50033330841DISCNM2H3101RH63GX50038918756D630H3101RH63GX50044803865D630H3101RH63GY50068854529NMDISCH3101RH63GY50069901516NM5376204-3163GX50016615873NMH3101RH63GY50075
H3101RH63GX50012832505D630H3101RH63GX50005713440NM630BH3101RH63GX50029281MHNE630H3101RH630X22919972258NM630H3100JY63GX50046210351NMH3101RH63GX50049281MWL630BH3101RH63GX50039281MWL630AH3101RH63GX50030434243DISH3101RH63GX50011LGMONT630H3101RH63GX50017540316NM6305791570630X22922804764D630CH3100JY630X22924UESS01NU03H3100JY63GX50048418404NU02H3101RH63GX50041083026202460918H3101RHNT2PG1800001BHNT80035376204-31-1
- Mfg. Lot or Serial # System ID Model, Catalogue or Code #
- Amount recalled
- 57 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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