General Electric Med Systems LLC GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System)
Brand
General Electric Med Systems LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
General Electric Med Systems LLC is recalling GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System due to Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
A letter dated Jan. 18, 2007, was sent to consignees describing the problem, product ,safety instructions and contact information. Software upgrades were promised for correction.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, DE, FL, GA, IL, IN, MD, MN, MO, NV, NJ, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WA, WI
Page updated: Jan 10, 2026