The Recall Desk
HighFDA (Devices)·Z-2995-2020·Announced 2020-09-30

GE Healthcare Recalls NM 830 Medical Detectors Due to Loose Screws

GE Healthcare is recalling 25 NM 830 detectors because rotor bearing screws were found loose. The devices are distributed in the US and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without reported hospitalizations or injuries fall into the High severity category (Score 3), representing a risk of harm where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 25 units of the NM 830 Model # H3910AC medical detectors. The recall was initiated because rotor bearing screws were found loose on the detectors.

The affected devices were distributed in the United States and in numerous countries outside the US, including Argentina, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, India, Israel, Italy, Japan, Korea (Republic of), Netherlands, Norway, Panama, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.

This recall is classified as Class II by the FDA. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with the defect.

The recalled product

Product
NM 830 Model # H3910AC
Manufacturer
GE Healthcare, LLC
Affected units
25

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 →