General Electric Med Systems LLC GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular)
Brand
General Electric Med Systems LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
General Electric Med Systems LLC is recalling GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular) 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