Recall Z-2437-2008 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare
Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, dia
| Date | Sep 20, 2008 (initiated Jul 25, 2008) |
| Status | Terminated |
| Reason | The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down. |
| Root cause | Device Design |
| Action | Consignees (Hospital Administrators; Hospital Risk Management Department; Mangers of Radiology/Cardiology; Radiologists/Cardiologists) were sent a "GE Urgent Medical Device Correction" letter dated July 2008. The letter described the affected products; the problem; and the user instructions, which state that the hospital should establish emergency workflow procedures to ensure patient safety should a component stop operating during a patient examination. Facilities should verify if their system has been impacted by checking if the catalog numbers listed are referenced on the PDB panel located |
| Quantity | 375 |
| Distribution | Nationwide Distribution --- including states of CA, FL, NY, AK, AL, AR, AZ, PA, FL ,CO, SC, CT, IA, DC, DE, GA, HI, IL , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NJ, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and GUAM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031637 | INNOVA 3100 GE Medical Systems, Aug 22, 2003 |
| 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 |