Recall Z-1522-2008 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Datex - Ohmeda, Inc
GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System
| Date | Sep 30, 2008 (initiated May 19, 2008) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room). |
| Root cause | Software design |
| Action | An Urgent Medical Device Correction letter, dated June 2008 was sent to customers The letter described the issue, affected products and provided short term user recommendations. GE developed a new software release that corrects this condition and will launch the corrective action to upgrade all affected systems. |
| Quantity | 87 |
| Distribution | Worldwide Distribution - AL, AZ, CA, FL,, GA, HI, IA,IL, IN, KY, LA,MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV, Puerto Rico. OUS to include: Australia, Byelarus, China, Denmark, France, Germany, Greece, Honduras, Iran, Iraq, Italy, Japan, Latvia, Lebano |
| FDA record | Open on fda.gov |