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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 21211Q/31311Q

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  Class 2 Device Recall Innova 21211Q/31311Q see related information
Date Initiated by Firm January 14, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-2043-2008
Recall Event ID 46796
510(K)Number K061163  
Product Classification Fluroscopic x-ray system - Product Code MQB
Product Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System.

The Innova Biplane systems are the first and only digital flat panel biplane system with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures.
Code Information ECXV1402B 4146492121 COR373252 N4192939 
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall		 Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system
FDA Determined
Cause 2		 Process control
Action Consignees were contacted by means of a Urgent Medical Device Correction letter dated 1/14/07. The letter is addressed to; Hospital Administrator, Hospital Risk Management Department, Manger of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the affected product and safety issue. The letter offers recommendations, solutions and provides contact information. If you have questions contact the firm: In the US contact the call center at 800-437-1171, option 4 and other countries should contact your local GE Healthcare field service representative.
Quantity in Commerce 4 units
Distribution USA: AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, OH OR, PA, SC, TN, TX, WI, AK, AL, AR, AZ, CT, DE, GA, HI, IA, ID, KS, KY,LA ME, MI, MN, MS, MT, ND, NE, NH, NY, OK, RI, UT, VA, WA, WI, WV. OUSA: Hungary Algeria Argentina Australia Austria Belarus Belgium Bosnia Brazil Bulgaria Canada Chile China Columbia Czech Republic Denmark Egypt Finland France Georgia Germany Greece Guadeloupe Guatemala Honduras Hong Kong India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Kuwait Latvia Lebanon Malaysia Malta Mexico Morocco Netherlands New Zealand Nigeria Norway Pakistan Panama Poland Portugal Puerto Rico Romania Russian Federation Saudi Arabia Singapore Spain Sweden Switzerland Syria Taiwan Thailand Turkey United Kingdom Uruguay Venezuela Yugoslavia
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 MEDICAL SYSTEMS, LLC
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