The Recall Desk
HighFDA (Devices)·Z-1257-2019·Announced 2019-05-08

GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems

GE Healthcare is recalling 57 Discovery NM 630 nuclear imaging systems because detector screws may not be secured correctly, risking loss of mounting redundancy.

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 in a medical device that could lead to the loss of a detector, posing a risk of harm to patients or equipment, but no injuries or illnesses have been reported.

Plain-English summary

GE Healthcare, LLC is recalling 57 units of the Discovery NM 630 nuclear imaging system. The recall is due to a manufacturing issue where detector screws may not have been secured correctly during installation of systems delivered with dismounted detectors.

This defect leads to the possible loss of one detector mounting design redundancy. The affected systems were distributed in the US and 18 other countries, including Austria, Canada, France, Germany, and the UK.

The source text does not specify instructions for consumers or healthcare providers on how to resolve the issue, nor does it report any injuries or illnesses associated with this defect.

The recalled product

Product
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Nuclear Imaging System
Hazard
Affected units
57

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Mfg. Lot or Serial # System ID Model

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

Related recalls

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Same hazard · structural defect

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