Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1264-2019·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Imaging Equipment
Hazard: mechanical-defect
mounting-failure
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.

See all 10 products in this recall →

Same manufacturer · GE Healthcare, LLC

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