General Electric Med Systems LLC GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System)
Brand
General Electric Med Systems LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
General Electric Med Systems LLC is recalling GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging Sys 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