Agency classClass IIOur severity:High FDA (Devices)·Z-1200-2014·Announced 2014-03-19

GE Healthcare Recalls Elscint APEX Helix Gamma Cameras for Motion Risk

GE Healthcare is recalling 3,062 Elscint APEX Helix gamma cameras due to a potential safety issue where the detector may drift toward the patient.

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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a score of 3.

Plain-English summary

GE Healthcare, LLC is recalling 3,062 units of the Elscint APEX Helix dual-head, multi-purpose, Slip-Ring, digital gamma camera. The recall affects units distributed worldwide, including 1,182 in the United States and 1,880 in other countries. The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

The recall is due to a potential safety issue related to unintended radial detector motion. This failure mode may occur during patient setup or at the end of a patient scan. The issue has been observed on a single system, where the detector moved to the home position and then slowly started drifting inward toward the patient. This movement generated both a visual and audio alert condition on both the console and the gantry.

The source text does not specify specific actions for consumers or healthcare providers, nor does it provide a list of specific serial numbers in the text body, noting only that all serial numbers are listed in Product 1.

The recalled product

Product: Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Imaging Equipment
Hazard: unintended-motion
patient-injury-risk

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)

all serial numbers are listed in Product 1.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · GE Healthcare, LLC

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Same hazard · unintended motion