The Recall Desk
HighFDA (Devices)·Z-2994-2020·Announced 2020-09-30

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.

What this means for you

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
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.

See all 8 products in this recall →