Agency classClass IIOur severity:High FDA (Devices)·Z-1263-2019·Announced 2019-05-08

GE Healthcare Recalls NM/CT 860 Systems Due to Detector Screw Issue

GE Healthcare is recalling six NM/CT 860 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 design redundancy, representing a risk of harm where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling six units of the NM/CT 860 system. These systems are intended for general Nuclear Medicine imaging procedures and Computed Tomography applications. The recall affects units distributed in the US and various international locations including Austria, Canada, France, Germany, and the UK.

The recall was initiated because, during installation of certain systems delivered with dismounted detectors, some detector screws may not have been secured correctly. This issue can lead to the possible loss of one detector mounting design redundancy. The source text does not report any injuries, illnesses, or deaths associated with this defect.

Healthcare facilities that have these specific systems should contact GE Healthcare for further instructions on how to address the potential mounting redundancy issue. The recall number is Z-1263-2019.

The recalled product

Product: NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Imaging Equipment
Hazard: structural-defect
equipment-failure
Affected units: 6

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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