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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical defect (loose screws) that compromises redundancy but does not present an immediate risk of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
GE Healthcare, LLC is recalling 16 units of the NM/CT 870 CZT system (Model/Catalogue/Code # H3906CW). The recall is due to a manufacturing issue where detector screws may not have been secured correctly during installation of systems delivered with dismounted detectors.
This defect leads to the possible loss of one detector mounting design redundancy. The affected units were distributed in the US and 19 other countries, including Austria, Canada, France, Germany, and the UK.
Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- 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
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 16
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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