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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innov

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 Class 2 Recall
GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innov
see related information
Date Posted May 14, 2013
Recall Status1 Terminated on March 13, 2014
Recall Number Z-1318-2013
Recall Event ID 65029
Premarket Notification
510(K) Numbers
K042053  K050489  K052157  K052412  K061163 
Product Classification Interventional Fluoroscopic X-Ray System - Product Code OWB
Product GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action GE Healthcare did not send out customer letters. GE Healthcare completed the correction by replacing the faulty relay in all affected systems. As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests recorded the repair of the affected units. Exceptions to completion of the service request were recorded as well. Records of field action completion will be retained per their processes and procedures. Should you have any questions or require additional information, please call (262) 548-2757.
Quantity in Commerce 713
Distribution Worldwide Distribution -- Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, HI, ID, IL , IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WY and WI., and the countries of Philippines, Peru, Paraguay, Panama, Mexico, Malaysia, Korea, Japan, Guatemala, Ecuador, Dominican Republic , Columbia, China, Chile, Canada, Brazil.,Argentina and Venezuela
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 = OWB and Original Applicant = GE HEALTHCARE
510(K)s with Product Code = OWB and Original Applicant = GE MEDICAL SYSTEMS, INC.
510(K)s with Product Code = OWB and Original Applicant = GE MEDICAL SYSTEMS, LLC
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