Recall Z-2361-2008 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare
Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment..
| Date | Sep 21, 2008 (initiated Jun 24, 2008) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems. The two conditions include 1). Due to insufficient securing of the connecting elements, the LCD vertical monitor support may disengage from its arm and fall on the tab |
| Root cause | Employee error |
| Action | The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance. |
| Quantity | 135 |
| Distribution | USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRAS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050489 | INNOVA 2100 Ge Medical Systems, LLC, Mar 11, 2005 |