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U.S. Department of Health and Human Services

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

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 Class 2 Recall
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ
see related information
Date Posted April 18, 2013
Recall Status1 Terminated on February 04, 2014
Recall Number Z-1142-2013
Recall Event ID 64884
Premarket Notification
510(K) Numbers
K033244  K042053  K050489  K052157  K052412  K061163 
K092004  K092639 
Product Classification Interventional Fluoroscopic X-Ray System - Product Code OWB
Product GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
Code Information Serial Number 00000000321WVO 00000000353WV3 00000000000000 00000000346WV7 00000000292WW3 00000000327WV7 00000000333WV5 00000000325WV1 00000000298WV0 00000000301WV2 00000000271WV7 00000000250WV1 00000000251WV9 00000000332WV7 00000000263WV4 00000000275WV8 00000000335WV0 00000000249WV3 00000000303WV8 00000000331WV9 00000000255WV0 00000000337WV6 00000000359WV0 00000000362WV4 00000000352WV5 00000000318WV6 00000000324WV4 00000000355WV8 00000000354WV1 00000000329WV3 00000000274WV1 00000000267WV5 00000000305WV3 00000000322WV8 00000000317WV8 00000000132WV1 00000000280WV8 00000000026WV5 00000000254WV3 00000000420WV0 00000000297WV2 00000XXX299WV8 00000000257WV6 00000000357WV4 00000000253WV5 00000000339WV2 00000000265WV9 00000000252WV7
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of co
FDA Determined
Cause 2
DESIGN: Labeling Design
Action A field action was initiated on October 21, 2011, and completed March 9, 2012, . The issue was corrected to all affected systems by applying the missing label onto the gantry. No recall letter was issued. For further questions please call (262) 513-4122.
Quantity in Commerce 48
Distribution Worldwide Distribution - Nationwide Distribution including the states of FL, IL, IN, LA, MI, MN, NJ, NM, NY, OH, PR, SC, TX and VA and the countries of Vietnam, Latvia, Italy, Israel, Indonesia, Hong Kong, United Kingdom, Finland, Spain, Czech Republic, Canada, Bahrain and Australia.
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 SCS
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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