Company:General Electric Med Systems LLC,
Date of Enforcement Report:6/6/2007
Class:ll
PRODUCT
a) GE Healthcare Innnova 4100/4100 IQ. Digital Fluoroscopic Imaging System
(Vascular Angiography System), Recall # Z-0869-2007;
b) GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System
(Cardiovascular Imaging System), Recall # Z-0870-2007;
c) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System
(Versatile cardiac and vascular), Recall # Z-0871-2007
REASON
Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control room) or in-room InnovaCentral/Touch-Screen.
CODE
a) 80140841 850060707 3016094100 3027444100 4134474100 5094744100 5135844100 5417684100 6309784100 7028804100 00171VAS01 00490VAS02 082406120016 082416130020 10091VAS01 190020RX09 201541SP1 251435I12 309672M4100 314569SJRM12 330489SPEC9 360754INNOVA 386HPOS1 412623LAB1 412623LAB3 414328INN4100 419696LAB1 530888ANG206 605333RM10 608263XMR 610954INNOVA41 617525IN1 617636IN1 630275G41 719560INN41 727791INNOVA 803256SP 804594ANGIO 804764CATH3 812238UN41 813615CL10 816943SP1 817433HSW4100 843577CL2 845368RM10 904202SP1 904BSSP 915577SP1 952993INNOVA2 970247INNOVA 972335LIB 972566INNOVA3 A5605732 COR359867 IL1043VA01 N4192927 NO1015VA04 R4211476 RU1106VA02 UC1129XR33 XF0151 XF0153 XF0154 XF0155 XF0200 YV0001 YV0002 YV0004 YV0006 YV0007;
b) 3027443100 7022333100 082416030003 082416040015 082416040019 082416120007 082416120010 082416160008 082416210006 082416220008 082449120007 214590PH3100 303425CL4 405272SCL2 405840OIC3100 412623LAB2 414647CL1 415925INV1 480728LAB2 516562INNOVA8 573882UMC1 717782INNOVA31A 718470INNOVA2 816943STJIC1 816985NKCI 918494IN31A 920169007 A5162256 A5333035 CS1006VA03 FI1064VA01 M40480151 M4163030 YV0027 YV0028 YV0029 YV0034 YV0035 YV0037;
c) 83016862101656 00060VAS02 00192VAS04 00282VAS02 00371VAS01 01065VAS01 082416070006 082416130024 212305CATH1 416480INNOVA 516562INNOVA6 516562INNOVA7 604682INNOVA1 604682INNOVA2 718470EP 770HMCCL1 781340IN3 83016102100795 83016242100936 83016802100516 83016802100866 83016802100916 83016802101197 83016862101656 83016862101916 858554INNOVA2 A4166952 A5164510 cee15663 HU1205VA01 M2068110 M2569315 M4198195 YV0061 YV0071
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter on March 26 & 27, 2007.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, Wisconsin, France. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
144 units
DISTRIBUTION
Nationwide and Internationally
