The Recall Desk
ModerateFDA (Devices)·Z-2998-2020·Announced 2020-09-30

GE Healthcare Recalls NM/CT 870 DR Systems Due to Loose Screws

GE Healthcare is recalling 31 NM/CT 870 DR systems because rotor bearing screws were found loose on the detector.

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, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a potential mechanical defect.

Plain-English summary

GE Healthcare, LLC is recalling 31 units of the NM/CT 870 DR Model # H3100AS. The recall was initiated because rotor bearing screws were found loose on the detector.

The affected units are distributed across 29 states in the United States and 27 countries internationally. Specific serial numbers and system IDs for the affected units are listed in the official recall documentation.

Healthcare facilities should contact GE Healthcare for instructions on how to address the loose screws and ensure the safety of the equipment.

The recalled product

Product
NM/CT 870 DR Model # H3100AS
Manufacturer
GE Healthcare, LLC
Affected units
31

Distribution

Part of a larger recall action

This product is one of 8 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 8 products in this recall →