CLASS II Device recall · Reported 19 Mar 2014 · FDA Enforcement Report

Varicam/VG and VG Hawkeye devices recalled by GE Healthcare

GE Healthcare is recalling Varicam/VG and VG Hawkeye devices, distributed nationwide in the US. The recall was initiated on 7 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall serial numbers are listed in Product 1

Quantity recalled3062 units (1182 US, 1880 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1199-2014
FDA event ID: 67464
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 7 Feb 2014
FDA classified: 13 Mar 2014
Reported: 19 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

7 Feb 2014	Recall initiated by company
13 Mar 2014	Classified by FDA	+34 days
19 Mar 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. N

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

Where it was distributed

Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

all serial numbers are listed in Product 1

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 67464

This product is part of a recall event; the main page for the event is Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring recalled.

Reported	Class	Recall	Company	Reason	Where
19 Mar 2014	CLASS II	Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring recalled	GE Healthcare	Device Malfunction	Nationwide
19 Mar 2014	CLASS II	Infinia and Infinia Hawkeye Nuclear Medicine Systems recalled	GE Healthcare	Device Malfunction	Nationwide

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