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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Innova 2100 IQ

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 Class 2 Device Recall GE Healthcare Innova 2100 IQsee related information
Date Initiated by FirmMarch 26, 2007
Date PostedJune 05, 2007
Recall Status1 Terminated 3 on October 21, 2008
Recall NumberZ-0871-2007
Recall Event ID 37723
510(K)NumberK023178 K031637 K042053 K050489 K052157 K052412 
Product Classification Digital Fluoroscopic Imaging System - Product Code MQB
ProductGE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular)
Code Information 83016862101656 00060VAS02 00192VAS04 00282VAS02 00371VAS01 01065VAS01 082416070006 082416130024 212305CATH1 416480INNOVA 516562INNOVA6 516562INNOVA7 604682INNOVA1 604682INNOVA2 718470EP 770HMCCL1 781340IN3 83016102100795 83016242100936 83016802100516 83016802100866 83016802100916 83016802101197 83016862101656 83016862101916 858554INNOVA2 A4166952 A5164510 cee15663 HU1205VA01 M2068110 M2569315 M4198195 YV0061 YV0071
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
ActionA 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 Commerce35
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = MQB
510(K)s with Product Code = MQB
510(K)s with Product Code = MQB
510(K)s with Product Code = MQB
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