Recall Z-0692-2008 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare
GE Innova 4100 / 4100 IQ. , 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)
| Date | Jan 31, 2008 (initiated Nov 15, 2007) |
| Status | Terminated |
| Reason | Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to send out X-rays without reporting an error message. The result was that the live imaging screen displayed an older "frozen" image until the operator released the |
| Root cause | Device Design |
| Action | Customers were contacted by means of an Urgent Medical Device Correction Letter on November 9, 2007. The letter described the product and the safety issue. The letter also made short term recommendations and described a long term solution, which is pending as an expected hardware and/or software modification that will be made at no cost. Short Term Recommendation: Take extra care when working with motionless anatomy or devices where there is little evident motion to warn you of the frozen image occurrence. Always completely shut down and restart the system (not just reset) immediately after |
| Quantity | 171 |
| Distribution | Worldwide-USA including states of AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, SC, TN, TX, WA, WI, AK, AL, AZ, ,CT, DE, HI, ID, KS, KY, ME, MI, MN, MS, MT, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, UT, VA, WV, and Puerto Rico and countries of Hungary, Korea, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042053 | INNOVA 4100, INNOVA 3100 Ge Medical Systems, Inc., Aug 26, 2004 |
| 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 |