Recall Z-0869-2007 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
General Electric Med Systems LLC
GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System)
| Date | Jun 5, 2007 (initiated Mar 26, 2007) |
| Status | Terminated |
| 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 |
| 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 | 70 |
| 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 Unite |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023178 | INNOVA 4100 Ge Medical Systems, Inc., Nov 26, 2002 |
| K031637 | INNOVA 3100 GE Medical Systems, Aug 22, 2003 |
| K042053 | INNOVA 4100, INNOVA 3100 Ge Medical Systems, Inc., Aug 26, 2004 |
| K050489 | INNOVA 2100 Ge Medical Systems, LLC, Mar 11, 2005 |
| K052157 | INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ Ge Medical Systems, LLC, Aug 25, 2005 |
| K052412 | INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ GE Healthcare, Sep 16, 2005 |