Recall Z-1092-2009 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Medical Systems, LLC
GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional
| Date | Mar 12, 2009 (initiated Mar 6, 2008) |
| Status | Terminated |
| Reason | GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover. |
| Root cause | Software design |
| Action | On site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units. |
| Quantity | 4 |
| Distribution | Worldwide Distribution -- USA including states of MD, TX, and VA and country of China. |
| FDA record | Open on fda.gov |