Reported May 8, 2019 · Terminated
NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately…
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 DR Product UsageThe GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce
- Lot codes and dates
- Mfg. Lot or Serial # System ID Model, Catalogue or Code # 870Y64037 SHIPPED (GON 4566933) H3100AS 870Y64040 SHIPPED (GON 4751375)
76 of 76 codes
H3100AS870X64011216844DR870H3100AS870X64024802775D870H3100AS870X64002206SCCANMH3100AS870X64032262741NUCH3100AS870X64001030020NU06H3100AS870Y64034514345BD870H3100AS870Y64035M54606132H3100AS870X64012X634445001H3100AS870X64007V2728113H3100AS870X64009M4016255H3100AS870X64026M40230109H3100AS870X64017M40240121H3100Q870X64018M40240122H3100Q870X64016499221NU01H3100AS870X64022A5173220H3100ASNT3DG1800003BHNS03035376204-70-60-1NT3DG1800002BHNS03025376204-70-60-1870X64025EMM0530H3100AS870Y64038MST01300H3100AS870X64029PL1031NM01
- Mfg. Lot or Serial # System ID Model, Catalogue or Code # 870Y64037 SHIPPED (GON 4566933) H3100AS 870Y64040 SHIPPED (GON 4751375)
- Amount recalled
- 27 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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