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.
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 3/5 (High).
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
- Hazard
- 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.
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