FDA (Devices) recall action 82582

GE Healthcare, LLC recalled 10 products on 2019-05-08

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2019-05-08
Critical: 0
Units: 226

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–10 of 10

HighFDA (Devices)··2019-05-08
GE Healthcare Recalls NM/CT 860 Systems Due to Detector Screw Issue
GE Healthcare is recalling six NM/CT 860 systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.
Product
NM/CT 860 Product Usage: The GE NM/CT 860 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
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HighFDA (Devices)··2019-05-08
GE Discovery NM/CT 670 DR Recalled for Potential Detector Screw Issue
GE Healthcare is recalling 11 Discovery NM/CT 670 DR systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.
Product
Discovery NM/CT 670 DR Product Usage: The 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, abnormal
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ModerateFDA (Devices)··2019-05-08
GE Discovery NM/CT 670 ES Recalled for Potential Detector Screw Issue
GE Healthcare is recalling three Discovery NM/CT 670 ES systems because detector screws may not have been secured correctly during installation.
Product
Discovery NM/CT 670 ES Product Usage: The 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, abnormali
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ModerateFDA (Devices)··2019-05-08
GE Healthcare Recalls 27 NM/CT 870 DR Systems Due to Detector Screw Issue
GE Healthcare is recalling 27 NM/CT 870 DR systems because detector screws may not be secured correctly, potentially compromising detector mounting redundancy.
Product
NM/CT 870 DR Product Usage: The 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
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0 states
HighFDA (Devices)··2019-05-08
GE Healthcare Recalls NM 830 Nuclear Imaging Systems for Screw Defect
GE Healthcare is recalling 37 Discovery NM 830 nuclear imaging systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.
Product
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various a
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ModerateFDA (Devices)··2019-05-08
GE Healthcare Recalls Discovery NM/CT 670 CZT Systems for Mounting Defect
GE Healthcare is recalling three Discovery NM/CT 670 CZT systems because detector screws may not be secured correctly, potentially compromising detector mounting redundancy.
Product
Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT 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 Medici
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HighFDA (Devices)··2019-05-08
GE Healthcare Recalls Optima NM/CT 640 Systems for Detector Screw Issue
GE Healthcare is recalling 35 Optima NM/CT 640 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.
Product
Optima NM/CT 640 Product Usage: The 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
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0 states
HighFDA (Devices)··2019-05-08
GE Healthcare Recalls NM/CT 850 Systems Due to Detector Screw Issue
GE Healthcare is recalling 31 NM/CT 850 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.
Product
NM/CT 850 Product Usage: The 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 v
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0 states
ModerateFDA (Devices)··2019-05-08
GE Healthcare Recalls 16 NM/CT 870 CZT Systems for Screw Issue
GE Healthcare is recalling 16 NM/CT 870 CZT systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.
Product
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT 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 syste
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0 states
HighFDA (Devices)··2019-05-08
GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems
GE Healthcare is recalling 57 Discovery NM 630 nuclear imaging systems because detector screws may not be secured correctly, risking loss of mounting redundancy.
Product
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by
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0 states