Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Innova 4100/4100IQ

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Innova 4100/4100IQ 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-2041-2008
Recall Event ID 46796
510(K)Number k023178  K052157  K052412  K061163  
Product Classification Fluroscopic x-ray system - Product Code MQB
Product Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector.
Code Information 3184734100 706774USP3 6309784100 6616324100 304256INNOVA 2035764100 352596SPEC 5135844100 719560INN41 303320OR41 303436ANGIO 3027444100 574294IN41 239939INNOVA 864255SF4100 3016094100 414649CL2 812858GWSP 212639ACT1 8014794100 4134474100 5033704100 509474SH41 201541SP1 281401T4100 918744JR4100 22925941V2 SHOWCASE4100 317887INNOVAPV 330489SPEC9 352333INVOR 386254HS1 386254HS2 386HPOS1 404GHSIR1 412647OR10 414649DVI 419696LAB1 505848V4100 508650IN41 509482HFI 512901NI4100 530888ANG206 541686SPR1 570321LAB2 610988INNOVA4 617636IN1 619229INNOVA1 623848SP 630275G41 630275G41B 650493ANGIOCT 662244GTSP 678EJCIR1 706291RINN2 706651SP1 706733SP1 708783SP4100 713375U4100 718630LIBERTY 727791INNOVA 770535N4100 803256SP 804594ANGIO 812238UN41 812825INNOVA1 813615CL10 817465AR4100 817922BA4100 843577CL2 845368RM10 850747IN4100 863687INV24 864573LAB2 865373SP 865481SUR 908522SP1 915577SP1 918682IN41 954MW4100 COR359867 DR4100 PEMBROKE4100 RADNETXV1 RHD4100 423495M4100E 423493I4100 8593134100 708WESTSUB4100 80140841 80180741 2194654100 4082594100 4105434100 4137484100 5094744100 5417684100 5703214100 5705224100 6082634100 7028804100 219326IN41 229228INNOV41C 22925941V 252816INNOVA 269226IN1 269226IN2 269983IN41 303839CL1 308534ANG 313876SP41 316651INNOVA41 317338PV3 360754INNOVA 401274IN41 412623LAB1 412623LAB3 414328INN4100 419251LAB1 508383IN4100 603650ANG1 608263ACT 608263XMR 617726RF2Y6 626359INNOVA 706291RINN 718206LIBERTY1 760633IR1 773878SWGANGIO1 801268INNOVA 804285CATH2 804764CATH3 810342A41 813558INTV 816943SP1 817433HSW4100 828298VASC 847842GS4100 856365ANGIO 903GS4100 904202SP1 904BSSP 952993INNOVA2 972335LIB 972566INNOVA3 985867INNOVA2 MIRAMAR41 WCATHLAB41 334286BSP 706278INNOVA1 561747IN4 252847PRS2 918744JC4100 850494WSP1 252816INNOVA 804594CATH 574535IN41 813745INTV 813972INTV 229228INNOV41V 508856OR41 717763INNOVA41 865541CCL5 SLIN4100 717763OR4100 239436CATH1 609652CATH3 80158241 216844INNOVA 77573841 727819SPSC ECXVINNOVARST3 404GHSIR2 989466INNOVA 404616INNOVA 352333VASC 812279INNOVA1 901726SP2 817255NH4100 828696IN41 304347INNOVA 918307SHIN4 724656ANG 757736INNOVA 315448RM4 941483INNOVA41 515263IL4100 4103374100 5138534100 8595724100 352401CATH 6029234100 5134754100 816276SP1 903CSM4100 319338VA4100 715369INN4100 407518SP3 956632INN4100 407518SP2 414961INN4100 904276SP 614293LIBERTY1 325670CATH 251435ICV5 315448RM5 573761SMA 3018774100 865693CCL3 614293LIBERTY2 229434INNOV 757398INNOVA 574647IN41 205759CL2 304255INNOVA 352401VASC 407SPECIALS 6012884100SP1 4438494100 740592INNOVA 804320CATH2B 478633INOV 8159374100 910063039 190020RX09 BG4037XR01 BE5005VA01 82406070010 82406310005 82416100016 82416130020 82416130021 82416130025 82416220006 82406120016 82416130010 82416130011 82416130013 82416160005 82406010011 82416130012 514842AINNOVA 613548INNOVA3 4163694100 250370INNOVA 306766INNOVA 416756INNOVA 519685INNOVA CS1054VA01 HC0220XR07 487692XR01 FI1015VA02 FI1015VA01 M1230007 00490VAS02 01278VAS01 10091VAS01 00137VAS01 00171VAS01 HU1039VA02 IE1100VA01 IL1043VA01 8.30062E+13 A5102671 A5163317 A5605732 C5603903 B5801711 XF0150 XF0151 XF0152 XF0153 XF0154 XF0155 XF0200 YV0007 XF0022 XF0149 YV0004 YV0003 YV0005 850060718 850060720 850060721 850060722 850060725 850060707 0850BOSNIA1 KW1001VA03 KW1018VA04 KW1013VA01 LB1037VA01 MA1020VA01 BRD0411 NO1015VA04 600042VA02 600050VA01 787620IN4100 787653INNOVA 600152VA01 RU1018VA03 RU1106VA02 SA1005VA06 SA1188VA03 06004VAS02 853060187 
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 306
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 HEALTHCARE
510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, INC.
510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC
-
-