Recall Z-0393-2011 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare, LLC
Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These system can be operated in a mobile or fixed site environment.
| Date | Nov 16, 2010 (initiated Aug 6, 2009) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential video splitter failure with certain Innova 2000 and 4100 X-ray systems that may impact patient safety. A potential video splitter failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray image display. Should this occur, the system cannot be recovered without service intervention. GE Healthcare has obse |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare sent an " Urgent Medical Device Correction" letter dated July 9, 2009, to Hospital Administrators / Risk mangers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter identified the product, described the Safety Issue, Affected Product Details, Safety Instructions Product correction and Contact Information. Hospitals were instructed to establish emergency workflow procedures should a component stop operating during a patient examination. A GE Healthcare service representative would contact each customer and correct all affected systems. For questions |
| Quantity | 365 |
| Distribution | Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX UT, VA, WA, WV, and WI, and the countries of UNITED KINGDOM, TUNISIA, TAIWAN, PROVINCE OF CHINA, SPAIN, SOUTH AFR |
| FDA record | Open on fda.gov |