| Class 2 Device Recall GE Healthcare Innova 4100/4100 IQ | |
Date Initiated by Firm | March 26, 2007 |
Date Posted | June 05, 2007 |
Recall Status1 |
Terminated 3 on October 21, 2008 |
Recall Number | Z-0869-2007 |
Recall Event ID |
37723 |
510(K)Number | K023178 K031637 K042053 K050489 K052157 K052412 |
Product Classification |
Digital Fluoroscopic Imaging System - Product Code MQB
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Product | GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System) |
Code Information |
80140841 850060707 3016094100 3027444100 4134474100 5094744100 5135844100 5417684100 6309784100 7028804100 00171VAS01 00490VAS02 082406120016 082416130020 10091VAS01 190020RX09 201541SP1 251435I12 309672M4100 314569SJRM12 330489SPEC9 360754INNOVA 386HPOS1 412623LAB1 412623LAB3 414328INN4100 419696LAB1 530888ANG206 605333RM10 608263XMR 610954INNOVA41 617525IN1 617636IN1 630275G41 719560INN41 727791INNOVA 803256SP 804594ANGIO 804764CATH3 812238UN41 813615CL10 816943SP1 817433HSW4100 843577CL2 845368RM10 904202SP1 904BSSP 915577SP1 952993INNOVA2 970247INNOVA 972335LIB 972566INNOVA3 A5605732 COR359867 IL1043VA01 N4192927 NO1015VA04 R4211476 RU1106VA02 UC1129XR33 XF0151 XF0153 XF0154 XF0155 XF0200 YV0001 YV0002 YV0004 YV0006 YV0007 |
Recalling Firm/ Manufacturer |
General Electric Med Systems LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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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 | 70 |
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 |
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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.
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510(K) Database | 510(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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