Recall Z-1616-2013 ยท OWB Interventional Fluoroscopic X-Ray System
GE Healthcare, LLC
GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures.
| Date | Jun 28, 2013 (initiated May 16, 2011) |
| Status | Terminated |
| Reason | GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems. |
| Root cause | Software design |
| Action | A Customer Letter was not originally sent. GE Healthcare has retrospectively re-assessed the reportability of the field action and has determined that the action should be reported to the FDA. GE Healthcare has already updated all of the affected Innova 3100 and Innova 4100 systems that were distributed. As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests have recorded the repair of the affected units. Exceptions to completion of the service request have been recorded as well. Records of field action completion have bee |
| Quantity | 48 |
| Distribution | Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033244 | DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION Ge Medical Systems, Inc., Oct 16, 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 |
| K061163 | INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT Ge Medical Systems, LLC, Jun 7, 2006 |