GE Healthcare Recalls Discovery NM 630 Systems Due to Loose Screws
GE Healthcare is recalling 62 Discovery NM 630 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 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 involves a structural defect (loose screws) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
GE Healthcare, LLC is recalling 62 units of the Discovery NM 630 Model # H3101RH 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 28 countries internationally. The source text does not specify the exact nature of the risk associated with the loose screws, nor does it report any injuries or illnesses.
Consumers and healthcare facilities should contact GE Healthcare for further instructions on how to address the issue with the affected systems.
The recalled product
- Product
- Discovery NM 630 Model # H3101RH
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 62
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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