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U.S. Department of Health and Human Services

Class 2 Device Recall Digital Fluoroscopic Imaging System

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 Class 2 Recall
Digital Fluoroscopic Imaging System
see related information
Date Posted May 19, 2009
Recall Status1 Open
Recall Number Z-1195-2009
Recall Event ID 51193
Premarket Notification
510(K) Numbers
K060259  K061163 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product Innova 2121-IQ/3131-IQ 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 product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment.
Code Information Product Number: 2121-IQ; Serial Numbers: 410614CV2, 253627INNOVA5, 808547QCV4, IE1100VA03, 713794LAB11, 936WH2121, 3108252121A, 416480INNOVA2, 3108252121B, 215576INNOVA2, 617636IN2121, 304526INNOVABP, 853060201, 541743CL5, 4105502121, 202782LABA, 857307IN32121, YV0362, YV0369, 610526LAB3, 610954BP1, 612273INNOVA3, 410614CV1, 857307IN12121, 857307IN22121, 319272EP, YV0363, 904202WCL1, 4146492121, FHORLEP4, FHORLEP5, 206598UWBP, 316268BIPLANE and HSRINNOVA1 and Product Number: 3131-IQ; Serial Numbers: 8184093131, 00440VAS04, 509474BIP, 561548BIP, 812238UNBPL, 615222BIH, 303425CL2, 516562INNOVA1, RO1095VA01, 6263973131, YV0462, YV0463, 853060198, 4144473131, BH1000VA01, 5135843131, 507385INN3131, 541382BP, YV0464, M4166990, YV0470, YV0166, 10307VAS01, 317338PV4, 309655FSP4A, YV0466, 773RES3131BP, 309655FSP2B, 713794LAB8, 630933INVLAB4, 518262BP1, 853060202, 00026VAS01, 410740CV, 834160004, 853060200, 301295EP, N4192939, COR373252, 2197383131, 718579INNOVABP, 83016900000000, 816932SL3131, 814877BP, 281637SL3131, 617525IN13131, FHORL3131, A5632421, FDO 0002769264, YV0471 and 834160005.
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on the image storage chain may result in the following situations: Record abort, Record not available, Fluorostore function not available, Review not available, Boot/Reset failure. Fluoroscopy imag
FDA Determined
Cause 2
DESIGN: Device Design
Action A GE Healthcare "Urgent Medical Device Correction" letter dated February 2, 2009 was sent to consignees via mail. The letter was directed to Hospital Administrator/Risk Manger, Managers of Radiology/Cardiology and Radiologists/Cardiologists addressing the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Further questions should be addressed to GE Healthcare at 1-800-437-1171.
Quantity in Commerce 85
Distribution Worldwide Distribution -- USA including states of CA, CO, FL, HI, IA, IL, IN, KS, MD, MA, MN, MO, NY, OH, OR, PA, TN, TX, WA, WV, WI and VA and countries of the United Kingdom, Romania, Japan, Taiwan, Bahrain, France, Malaysia, India, Canada, Chile, Indonesia, Ireland and Italy.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC
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