Recall Z-1043-2007 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).
| Date | Jul 10, 2007 (initiated Mar 26, 2007) |
| Status | Terminated |
| Reason | Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patient contouring. Usage of Innova Sense patient contouring for such devices could potentially lead to patient injury. |
| Root cause | Other |
| Action | A "GE Healthcare Urgent: Safety Notice" dated January 24, 2007 was sent to consignees describing the product, problem, safety instructions, product correction and contact information. |
| Quantity | 205 |
| Distribution | Worldwide, including USA, Guam, Canada, Australia, China, India, Japan, Korea, Malaysia, New Zealand, Algeria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Jordan, Morocco, Norway, Poland, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Syria, Turkey, and United Kingd |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023178 | INNOVA 4100 Ge Medical Systems, Inc., Nov 26, 2002 |
| K031637 | INNOVA 3100 GE Medical Systems, Aug 22, 2003 |
| K042053 | INNOVA 4100, INNOVA 3100 Ge Medical Systems, Inc., Aug 26, 2004 |
| K050489 | INNOVA 2100 Ge Medical Systems, LLC, Mar 11, 2005 |
| 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 |