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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 Posted April 18, 2013
Recall Status1 Terminated 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 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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