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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Innova 3100/ 3100 IQ

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  Class 2 Device Recall GE Healthcare Innova 3100/ 3100 IQ see related information
Date Initiated by Firm March 26, 2007
Date Posted June 05, 2007
Recall Status1 Terminated 3 on October 21, 2008
Recall Number Z-0870-2007
Recall Event ID 37723
510(K)Number K023178  K031637  K050489  K042053  K052412  K052157  
Product Classification Digital Fluoroscopic Imaging System - Product Code MQB
Product GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System)
Code Information 3027443100 7022333100 082416030003 082416040015 082416040019 082416120007 082416120010 082416160008 082416210006 082416220008 082449120007 214590PH3100 303425CL4 405272SCL2 405840OIC3100 412623LAB2 414647CL1 415925INV1 480728LAB2 516562INNOVA8 573882UMC1 717782INNOVA31A 718470INNOVA2 816943STJIC1 816985NKCI 918494IN31A 920169007 A5162256 A5333035 CS1006VA03 FI1064VA01 M40480151 M4163030 YV0027 YV0028 YV0029 YV0034 YV0035 YV0037
Recalling Firm/
Manufacturer		 General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
Manufacturer Reason
for Recall		 Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control room) or in-room InnovaCentral/Touch-Screen
FDA Determined
Cause 2		 Other
Action A letter dated Jan. 18, 2007, was sent to consignees describing the problem, product ,safety instructions and contact information. Software upgrades were promised for correction.
Quantity in Commerce 39
Distribution Worldwide Distribution: USA states including-AZ,CA,CO,DE,FL,GA,IL,IN, MD,MN,MO,NJ,NV,NY,OH,OK,OR,PA,SC,SD,TX, UT, VA,WA,WI, and countries of Canada, Belgium, China, Czech Republic, Finland, France, Germany, Hungary, India, Isreal, Italy, Japan, Korea, New Zealand, Norway, Russia, Spain, and United Kingdom.
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 = MQB and Original Applicant = GE HEALTHCARE
510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS
510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, INC.
510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC
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