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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 Device Recall GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ see related information
Date Initiated by Firm October 21, 2011
Date Posting Updated April 18, 2013
Recall Status1 Terminated 3 on February 04, 2014
Recall Number Z-1142-2013
Recall Event ID 64884
510(K)Number K033244  K042053  K050489  K052412  K052157  
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 WI 53188-1615
For Additional Information Contact
262-513-4122
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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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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