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Class 2 Device Recall GE Innova 2100IQ |
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Date Initiated by Firm |
June 06, 2006 |
Date Posted |
September 28, 2007 |
Recall Status1 |
Terminated 3 on December 08, 2015 |
Recall Number |
Z-1088-2007 |
Recall Event ID |
44936 |
510(K)Number |
K050489
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Product Classification |
Fluoroscopic Imaging System, - Product Code MQB
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Product |
GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. GE Healthcare Americas P.O.Box 414, Milwaukee, Wisconsin 53201, U.S.A. |
Code Information |
00000459256BU4, 00000459553BU4, 00000459554BU2, 00000459555BU9, 00000459556BU7, 00000459557BU5, 00000460056BU5, 00000460057BU3, 00000460058BU1, 00000460059BU9, 00000460060BU7, 00000460063BU1, 00000460065BU6, 00000460066BU4, 00000460067BU2, 00000461642BU1, 00000461643BU9, 00000461644BU7, 00000461645BU4, 00000462898BU8, 00000462899BU6, 00000462900BU2, 00000462901BU0, 00000462902BU8, 00000462903BU6, 00000462904BU4, 00000462905BU1, 00000462906BU9, 00000462907BU7, 00000463613BU2, 00000463630BU4, 00000463631BU2, 00000463632BU0, 00000463633BU8, 00000463634BU6, 00000463636BU1, 00000463637BU9, 00000463638BU7, 00000463639BU5, 00000463841BU7, 00000467440BU4, 00000467441BU2, 00000467442BU0, 00000467443BU8, 00000467444BU6, 00000467445BU3, 00000467446BU1, 00000467447BU9, 00000467448BU7, 00000467449BU5, 00000467451BU1, 00000469541BU7, 00000469542BU5, 00000469543BU3, 00000469544BU1, 00000469545BU6, 00000469546BU6, 00000469547BU4, 00000469548BU2, 00000469549BU0, 00000469550BU8, 00000470643BU8, 00000470644BU6, 00000470645BU3, 00000470646BU1, 00000470647BU9, 00000470648BU7, 00000470649BU5, 00000470650BU3, 00000470651BU1, 00000470652BU9, 00000471493BU7, 00000471494BU5, 00000471495BU2, 00000471496BU0, 00000471497BU8, 00000471498BU6, 00000471499BU4, 00000471500BU9, 00000471501BU7, 00000471502BU5, 00000472676BU6, 00000477489BU9, 00000477490BU7, 00000477491BU5, 00000477492BU3, 00000477493BU1, 00000477494BU9, 00000477495BU6, 00000477496BU4, 00000477497BU2, 00000477498BU0, 00000477893BU2, 00000479230BU5, 00000479231BU3, 00000479232BU1, 00000479233BU9, 00000479234BU7, 00000479235BU4, 00000479236BU2, 00000479237BU0, 00000479238BU8, 00000479239BU6, 00000479937BU5, 00000479945BU8, 00000479946BU6, 00000479947BU4, 00000479948BU2, 00000479949BU0, 00000479950BU8, 00000479951BU6, 00000479952BU4, 00000479953BU2, 00000479954BU0, 00000482511BU3, 00000482512BU1, 00000482513BU9, 00000482514BU7, 00000482515BU4, 00000482516BU2, 00000482517BU0, 00000482518BU8, 00000482519BU6, 00000482520BU4, 00000484054BU2, 00000485072BU3, 00000485074BU9, 00000485075BU6, 00000485076BU4, 00000485077BU2, 00000485078BU0, 00000485079BU8, 00000485080BU6, 00000485081BU4, 00000487465BU7, 00000487466BU5, 00000487469BU9, 00000487470BU7, 00000487471BU5, 00000487472BU3, 00000487473BU1, 00000487474BU9, 00000491019BU6, 00000491020BU4, 00000491021BU2, 00000491022BU0, 00000491023BU8, 00000491025BU3, 00000491027BU9, 00000491028BU7, 00000491032BU9, 00000492823BU0, 00000492824BU8, 00000492825BU5, 00000492827BU1, 00000492828BU9, 00000492830BU5, 00000492831BU3, 00000494960BU8, 00000504480BU5, 00000508755BU6, 00004600057BU3 |
Recalling Firm/ Manufacturer |
GE Healthcare 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact |
262-312-7700
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Manufacturer Reason for Recall |
The systems do not contain a certification label on the C2 Cabinet (Beam-limiting control).
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FDA Determined Cause 2 |
Other |
Action |
Starting on June 6, 2007, a GE service engineer will go to each affected site to affix certification labels on the affected devices. |
Quantity in Commerce |
161 |
Distribution |
World wide Distribution includes: AL, AR, AZ, CA,, CO, CT FL, GA, HI, ID, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI,and WV, and countries of ; Algeria, Australia, China, Denmark, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, New Zealand, Norway, Poland, Saudi Arabia, Singapore, Switzerland, Syrian Arab Republic, Turkey, 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 and Original Applicant = GE MEDICAL SYSTEMS, LLC
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