Reported May 8, 2019 · Terminated
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by…
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/CT 670 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 # DRGX56002 SHIPPED (GON 4683652)SHIPPED (AO 1614951)
H3100BTDDRX34058909558D670NMH3100ANDDRX34056650723D670H3100ANDDRX34053
H3100ANDRGX56005614CVA6702H3100BTDRGX56017110002NU06H3100BTDRGX56004403343D670AH3100BTDRGX56018X7410502H3100BTDRGX56009083026206531618H3100BTDRGX56012STD01300H3100BTDDRX3405500362NUC04H3100AN
- Mfg. Lot or Serial # System ID Model, Catalogue or Code # DRGX56002 SHIPPED (GON 4683652)
- Amount recalled
- 11 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new GE Healthcare, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.