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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Innova

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  Class 2 Device Recall GE Healthcare Innova see related information
Date Initiated by Firm February 05, 2007
Date Posted June 09, 2007
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-0915-2007
Recall Event ID 37775
510(K)Number K023178  
Product Classification Digital Fluoroscopic Imaging - Product Code MQB
Product GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography System).
Code Information 5135844100 5136864100 314569SJRM12 530888ANG206 713375U4100 804320CATH2B 804764CATH3 812238UN41 812238UN41 813615CL10 843577CL2 972566INNOVA3 80140841 3016094100 3027444100 4134474100 5033704100 5094744100 5417684100 6309784100 7028804100 201541SP1 251435I12 252847PRS3 309672M4100 330489SPEC9 360754INNOVA 386HPOS1 412623LAB1 412623LAB3 414328INN4100 419696LAB1 509482HFI 605333RM10 608263XMR 610954INNOVA41 617525IN1 617636IN1 630275G41 678EJCIR1 719560INN41 727791INNOVA 770535N4100 803256SP 804594ANGIO 816943SP1 817433HSW4100 845368RM10 904202SP1 904BSSP 908522SP1 915577SP1 918682IN41 952993INNOVA2 970247INNOVA 972335LIB COR359867 00171VAS01 00490VAS02 10091VAS01 190020RX09 600152VA01 A5605732 BRD0411 IE1100VA01 IL1043VA01 N4192927 NO1015VA04 R4211476 RU1106VA02 UC1129XR33 850060707 850060722 082406120016 082416130020 XF0154 XF0155 XF0200 306766INNOVA 519663INNOVA2 
Recalling Firm/
Manufacturer		 General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
Manufacturer Reason
for Recall		 Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller that may impact patient or staff safely.
FDA Determined
Cause 2		 Other
Action Consignees were contacted via a letter "Urgent: Safety Notice" dated 2/5/07. The letter described the safety issue, affected product, safety instructions and product correction contact information. -This is the short-term fix, GE is working on a correction that will be installed at each site as the long term correction
Quantity in Commerce 80
Distribution Class II Recall - Worldwide Distribution --- USA including states of WV, WI, WA, VA, UT, TX, TN, SD, SC, PA, OR, OK,OH, NY, NV, NJ, NE, NC, MT, MO, MN, MI, ME, MD, MA, LA, KY, KS, IN, IL, ID, HI, GU, GA, FL, DE, CT, CO, CA, AZ, AL, AK and countries of UNITED KINGDOM, TURKEY, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SAUDI ARABIA, RUSSIA, POLAND, NORWAY, NEW ZEALAND, THE NETHERLANDS, MOROCCO, MALAYSIA, KOREA, JORDAN, JAPAN, ITALY, ISREAL, IRELAND, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, FINLAND , DENMARK, CZECH REPUBLIC, CHINA, CANADA, BELGIUM, AUSTRALIA, and ALGERIA.
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, INC.
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