The Recall Desk
HighFDA (Devices)·Z-1199-2014·Announced 2014-03-19

GE Healthcare Recalls Varicam and VG Hawkeye Imaging Devices

GE Healthcare is recalling Varicam and VG Hawkeye nuclear medicine devices due to a potential safety issue where the detector may drift toward the patient.

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 is classified as FDA Class II and involves a risk-of-harm product (unintended motion toward a patient) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling 3,062 units of Varicam/VG and VG Hawkeye nuclear medicine imaging devices. The recall is due to a potential safety issue involving unintended radial detector motion. This failure mode has been observed on a single system, where the detector moved to the home position and then slowly drifted inward toward the patient. The movement generated visual and audio alerts on both the console and the gantry.

The affected devices are used for general nuclear medicine imaging procedures to detect radioisotope tracer uptake in the patient body. The devices are distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam) and numerous international locations. All serial numbers for the affected units are listed in the official recall documentation.

Healthcare facilities should contact GE Healthcare for instructions on how to address this issue. The recall is classified as Class II by the FDA, indicating that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
GE Healthcare Varicam/VG and VG Hawkeye devices 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 scanning modes supported by various a
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard

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 →

Related recalls

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Same hazard · unintended motion

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