Reported Jan 20, 2021 · Ongoing
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery…
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 670 DR (Model H3100BT)NM/CT 870 DR (Model 3100Q and H3100AS)Discovery NM670 Pro (Model 3100XB)Discovery 670
- ES (Model H3100XF) - Product Usageintended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities
- and disorders such NM SystemGeneral 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
- Lot codes and dates
- Discovery 670 DR (Model H3100BT)
- Serial Numbers
DRGY56033DRGY56037DRGY56035DRGY56030DRGZ56043DRGZ56042DRGY56032DRGY56031DRGY56034DRGY56036 NM/CT 870 DR (Model 3100Q)
- Serial Numbers
870Y64066and (Model H3100AS)
- Serial Numbers
870Y64077870Y64064870Y64081870Y64079870Y64067870Y64074870Z64117870Y64078870Y64080870Y64069870Y64085870Z64121870Z64119870Z64122870Y64056870Y64063870Z64114870Z64115870Y64068870Y64082870Z64116870Z64120870Y64065870Y64084870Y64061870Y64083870Z64113870Y64070870Z64123870Y64058870Z64118870Y64057 Discovery NM670 Pro (Model 3100XB)
- Serial Numbers
PRGY52027PRGY52031PRGZ52047PRGZ52046PRGY52028PRGZ52048PRGY52029PRGY52030 Discovery 670 ES (Model H3100XF)
- Serial NumbersESGZ53005
- Amount recalled
- 52 untits
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
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.
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