Recall Z-1036-2009 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Medical Systems, LLC
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). The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended
| Date | Sep 24, 2009 (initiated Nov 4, 2008) |
| Status | Terminated |
| Reason | One of three copper spectral filters could remain within the x-ray while the system displays no spectral filter. The displayed Air Kerma rate and thus cumulative Air Kerma are overestimated. The Air Kerma rate may be over estimated by up to 60%. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Affected customers were notified by means of a Important Electric Product Radiation Warning letter. GE field personnel will be replacing the collimators. |
| Quantity | 166 |
| Distribution | Nationwide Distribution -- AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052412 | INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ GE Healthcare, Sep 16, 2005 |