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U.S. Department of Health and Human Services

Class 2 Device Recall Helix

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 Class 2 Recall
Helix
see related information
Date Posted March 13, 2014
Recall Status1 Terminated on November 03, 2014
Recall Number Z-1200-2014
Recall Event ID 67464
Premarket Notification
510(K) Number
K022960 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
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 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.
Code Information all serial numbers are listed in Product 1.
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
For Additional Information Contact GE Healthcare Call Center
800-437-1171
Manufacturer 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
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
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