Z-0870-2007

GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System)

Name: Z-0870-2007 GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System)
Creator: General Electric Med Systems LLC
Published: 2007-03-26
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-03-26 / Terminated / root cause: software

FDA source

General Electric Med Systems LLC began a recall of GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System) on 2007-03-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0870-2007
Status: Terminated
Initiated: 2007-03-26
Posted: 2007-06-05
Terminated: 2008-10-21
Recalling firm: GE Healthcare
Product: GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System)
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: 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
Root cause tag: software
FDA root cause: Other
Action: 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.
Quantity in commerce: 39
Distribution: Worldwide Distribution: USA states including-AZ,CA,CO,DE,FL,GA,IL,IN, MD,MN,MO,NJ,NV,NY,OH,OK,OR,PA,SC,SD,TX, UT, VA,WA,WI, and countries of Canada, Belgium, China, Czech Republic, Finland, France, Germany, Hungary, India, Isreal, Italy, Japan, Korea, New Zealand, Norway, Russia, Spain, and United Kingdom.
Product codes and lots: 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

Product code MQB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)