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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 2121IQ/31311Q Biplane Cardiovascular Imaging System

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  Class 2 Device Recall Innova 2121IQ/31311Q Biplane Cardiovascular Imaging System see related information
Date Initiated by Firm August 05, 2009
Date Posted November 17, 2010
Recall Status1 Terminated 3 on January 16, 2014
Recall Number Z-0407-2011
Recall Event ID 56967
510(K)Number K061163  
Product Classification Solid state x-ray image (flat panel/digital imager) - Product Code MQB
Product Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures.
The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
Code Information 2121IQ 2036882121 4146492121 05448VAS01 206598UWBP 214590EP2121 215576INNOVA2 253627INNOVA5 301295CATH 304526INNOVABP 3108252121A 3108252121B 316268BIPLANE 319272EP 4105502121 410614CV1 410614CV2 541743CL5 610526LAB3 610954BP1 612273INNOVA3 617636IN2121 713794LAB11 857307IN12121 857307IN22121 857307IN32121 904202WCL1 936WH2121 FHORLEP4 FHORLEP5 IE1100VA03 MCDEP VAD2121  3131IQ 4144473131 00026VAS01 00243VAS02 00440VAS04 10307VAS01 2197383131 281637SL3131 301295EP 309655FSP2B 309655FSP4A 317338PV4 410740CV 509474BIP 5135843131 540776LGVAS2 541382BP 542120XR02 561495DLBIP 561548BIP 561881BP1 615222BIH 617525IN13131 6263973131 630933INVLAB4 650493BIPL 713794LAB8 718579INNOVABP 773RES3131BP 814877BP 816932SL3131 817465AR3131 8184093131 985867INNOVA31 COR373252 COR373295 EG1000VA01 N4192939                                                                                                                                                                                                                                                                                                                                                                                         
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to maintain fluoroscopy availability for approximately 5 minutes should there be a main power failure. Once power is restored, the equipment power will be returned to the main hospital power. UPS fluoro ba
FDA Determined
Cause 2		 Nonconforming Material/Component
Action GE Healthcare sent an "Urgent Medical Device Correction" letter on August 5, 2009 to all Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letter was dated August 4, 2009, and described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For questions regarding this recall call (262) 548-2731.
Quantity in Commerce 32 (2121IQ); 37 (3131IQ)
Distribution Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK ,OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI and the countries of ANGOLA, BELARUS, BULGARIA, CANADA, EGYPT, FRANCE, GERMANY, HUNGARY, IRELAND, MEXICO, ITALY, NIGERIA, NORWAY, POLAND, PORTUGAL, RUSSIAN FEDERATION, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, TUNISIA, TURKEY, and the 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 MEDICAL SYSTEMS, LLC
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