Reported May 8, 2019 · Terminated
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging…
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?
- Optima NM/CT 640 Product UsageThe GE Optima NM/CT 640 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 (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies
- Lot codes and dates
- Mfg. Lot or Serial # System ID Model, Catalogue or Code #RMCOPTIMA
ONMX26520714456OPT15474055ONMX26518408559O640H3100JZONMX26529408559O640H3100JZONMX26528970298NM5474055ONMX26537303425O6405474055ONMX26538303689O6405474055ONMX26539970298NM15474055ONMX26519860358O640H3100JZONMX26530302430NUC640H3100JZONMX26512515699NM1H3100JZONMX26503630933NM6402H3100JZONMX26513316962NM640H3100JZONMX26511443777NM5474055ONMX26542301315NMOPTIMAH3100JZONMX26510906225NMCTH3100JZONMX265144695537NM11H3100JZONMX26507
SHIPPED (GON 4562299) H3101RL 64GY51006 SHIPPED (AO 1635868) H3101RL 64GY51007 SHIPPED (GON 4562663)H3100JZONMX26515701239NM640B5474055ONMX26534402473OPT640H3100JZ64GX51001
H3101RLONMX26544740593OPT640H3100JZONMX26531614MCMN6405474055ONMX26517513870NM640H3100JZONMX26524614GCNM64025474055ONMX26527614GCNM640H3100JZONMX26546605347NM640H3100JZONMX26516469993NMH3100JZONMX26476608263OPT640H3100JZONMX26480403529D640H3100JZONMX265024534444NM12H3100JZONMX26536HR4052NM03H3100JZONMX26521NTE042H3100JZONMX26525ZA2719CT01H3100JZ
- Mfg. Lot or Serial # System ID Model, Catalogue or Code #
- Amount recalled
- 35 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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