Reported May 8, 2019 · Terminated
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for…
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 850 Product UsageThe GE NM/CT 850 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 system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images
- Lot codes and dates
- Mfg. Lot or Serial # System ID Model, Catalogue or Code #SHIPPED (AO 1623723) H3907AD 85EX67020 SHIPPED (GON 4745963) H3907AD 85EX67023 SHIPPED (GON 4704278) H3907AD 85EX67024 SHIPPED (GON 4710759) H3907AD 85EY67025 SHIPPED (AO 1638499) H3907AD 85EY67026 SHIPPED (AO 1638498) H3907AD 85EY67028 SHIPPED (AO 1638502)
85EX670184740081NM11H3907AD85EX67001203789NM850H3907AD850X61005319768NMCTH3907AD850Y61006319768NMH988H3907AD85EX67022847618NMH3907AD85EX67019773975NMCTH3907AD85EX67008779696NM850H3907AD85EX67017318212NMH3907AD85EX67012781729NMH3907AD85EX67015
SHIPPED (GON 4640067)H3907AD85EX67009513732NM578201385EX67002419289D850H3907AD85EX67016972969NMH3907AD85EX67004571472NM850H3907AD85EX67021
H3907AD85EX67010804289NM850AH3907AD85EX67011804281NM850AH3907AD85EX67005715717NMCTH3907AD85EX67013920456NMH3907AD850X61004030601NU06H3907AD850X61002NS0001H3907ADNT3BG1900001BHNS04015376204-50-185EX67003PL1692NM05H3907AD85EX67014PPR59076H3907AD850Y61007SK1082NM02H3907AD
- Mfg. Lot or Serial # System ID Model, Catalogue or Code #
- Amount recalled
- 31 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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