GE Healthcare Recalls Discovery 670 DR Units Due to Loose Screws
GE Healthcare is recalling 20 Discovery 670 DR units 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 describes a mechanical defect (loose screws) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
GE Healthcare, LLC is recalling 20 units of the Discovery 670 DR (Model # H3100BT) medical device. 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 20 units are listed in the official recall documentation.
Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the loose screws on the affected devices.
The recalled product
- Product
- Discovery 670 DR Model # H3100BT
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 20
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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