Agency classClass IIOur severity:High FDA (Devices)·Z-1261-2019·Announced 2019-05-08

GE Healthcare Recalls NM 830 Nuclear Imaging Systems for Screw Defect

GE Healthcare is recalling 37 Discovery NM 830 nuclear imaging systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

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 in a medical device that could lead to loss of mounting redundancy, posing a risk of harm, but no injuries or illnesses have been reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling 37 units of the Discovery NM 830 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 can lead to the possible loss of one detector mounting design redundancy.

The affected systems are distributed in the US and internationally, including Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, and the UK. The specific serial numbers and system IDs for the affected units are listed in the official recall documentation.

Healthcare facilities should contact GE Healthcare to verify if their specific unit is affected and to arrange for inspection and repair of the detector mounting screws to ensure proper security and redundancy.

The recalled product

Product: NM 830 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 various…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Nuclear Imaging System
Hazard: structural-defect
equipment-failure
Affected units: 37

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 →

Same manufacturer · GE Healthcare, LLC

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