Z-1199-2014Class II

GE Healthcare Varicam/VG and VG Hawkeye devices

Name: Z-1199-2014 GE Healthcare Varicam/VG and VG Hawkeye devices
Creator: GE Healthcare, LLC
Published: 2014-02-07
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-02-07 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of 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... on 2014-02-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1199-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-07
Posted: 2014-03-13
Terminated: 2014-11-03
Recalling firm: GE Healthcare
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 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.
Product code: KPS System, Tomography, Computed, Emission
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
Root cause tag: design
FDA root cause: Device Design
Action: GE sent an Urgent Medical Device Correction letter, dated 2/7/2014 to medical facilities beginning 2/7/2014. The letter was addressed to Manager of Nuclear Medicine, Hospital Administrators/Risk Managers, and Managers of Radiology/Cardiology. The letter described the issue and provided safety instructions. For Infinia and Infinia Hawkeye, Millennium VG, VG Hawkeye and VariCam nuclear Medicine Systems, the letter stated that a software upgrade would correct the issue. For the Helix Nuclear Medicine Systems, GE stated that a software upgrade can not be applied to the older systems and that additional information will be provided at a later date. UPDATE ON THE HELIX DEVICES: An Urgent Medical Device Correction letter, dated 4/7/2014 was sent to customers who still have a GE Helix Nuclear Medicine System. The letter requested to immediately stop using the device, and reiterated the March 2008 letter in which GE stated that they would no longer be able to offer full service support. The main reason for this was due to unavailability of parts required for maintenance and repair of the device because outside suppliers cease to produce the older parts. GE offered assistance in removal and disposal of the Helix system.
Quantity in commerce: 3062 units (1182 US, 1880 OUS)
Distribution: 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.
Product codes and lots: all serial numbers are listed in Product 1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1199-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1198-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-13
Z-1199-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-13
Z-1200-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-13

Product code KPS

K022960Class IIGe Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa / cleared 2002-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)