GE Healthcare Recalls NM/CT 870 CZT Systems Due to Loose Screws
GE Healthcare is recalling 15 NM/CT 870 CZT 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, and the source text does not report any injuries, illnesses, or deaths. The hazard is a mechanical defect (loose screws) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
GE Healthcare, LLC is recalling 15 units of the NM/CT 870 CZT (Model # H3906CW) medical imaging systems. 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 15 affected units are listed in the official recall documentation.
Healthcare facilities should contact GE Healthcare for instructions on how to address the loose screws. Patients and consumers should not use the affected equipment until the issue is resolved by the manufacturer.
The recalled product
- Product
- NM/CT 870 CZT Model # H3906CW
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 15
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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