The Recall Desk
ModerateFDA (Devices)·Z-1258-2019·Announced 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.

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, which typically corresponds to a moderate severity score when no injuries or illnesses are reported and the hazard is a mechanical defect rather than a direct health threat.

Plain-English summary

GE Healthcare, LLC is recalling three units of the Discovery NM/CT 670 CZT system, model H3906CT. These systems are intended for general Nuclear Medicine imaging procedures and Computed Tomography applications. The recall affects specific units identified by System IDs AD7X38019, AD7X38022, and AD7X38020.

The recall was initiated because, during installation of certain systems delivered with dismounted detectors, some detector screws may not have been secured correctly. This defect leads to the possible loss of one detector mounting design redundancy. The affected units were distributed in the US and several international locations, including Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, and the UK.

This is an FDA Class II recall. Healthcare facilities should contact GE Healthcare for instructions on how to secure the detectors properly. No injuries or illnesses have been reported in connection with this defect.

The recalled product

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
Manufacturer
GE Healthcare, LLC
Affected units
3

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.

See all 10 products in this recall →