Recall Z-0913-2007 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
General Electric Med Systems LLC
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular imaging system.).
| Date | Jun 9, 2007 (initiated Feb 5, 2007) |
| Status | Terminated |
| Reason | Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller, that may impact patient or staff safely. |
| Root cause | Other |
| Action | Consignees were contacted via a letter "Urgent: Safety Notice" dated 2/5/07. The letter described the safety issue, affected product, safety instructions and product correction contact information. -This is the short-term fix, GE is working on a correction that will be installed at each site as the long term correction |
| Quantity | 201 |
| Distribution | Class II Recall - Worldwide Distribution --- USA including states of WV, WI, WA, VA, UT, TX, TN, SD, SC, PA, OR, OK,OH, NY, NV, NJ, NE, NC, MT, MO, MN, MI, ME, MD, MA, LA, KY, KS, IN, IL, ID, HI, GU, GA, FL, DE, CT, CO, CA, AZ, AL, AK and countries of UNITED KINGDOM, TURKEY, SYRIA, SWITZERLAND, SWED |
| 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 |