GE Healthcare Recalls NM/CT 850 Systems Due to Loose Rotor Bearing Screws
GE Healthcare is recalling 25 NM/CT 850 systems because rotor bearing screws were found loose on the detector.
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 source text describes a mechanical defect (loose screws) but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a potential risk of harm without reported adverse events.
Plain-English summary
GE Healthcare, LLC is recalling 25 units of the NM/CT 850 (Model Number: H3907AD) medical imaging systems. The recall was initiated because rotor bearing screws were found loose on the detector.
The affected units were distributed in the United States and various international locations, 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.
Healthcare facilities should contact GE Healthcare for instructions on how to address the loose screws. No specific instructions for immediate patient action are provided in the source text, but the defect involves a mechanical component of the imaging detector.
The recalled product
- Product
- NM/CT 850 Model Number: H3907AD
- 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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