Recall Z-2147-2008 ยท IZH System, X-Ray, Mammographic
GE Healthcare
GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography examinations.
| Date | Sep 26, 2008 (initiated Jul 1, 2008) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your Senographe DS Acquisition system and could impact patient safety. If the Stereotactic Positioner is removed when the examination arm is at 33 degrees and, th |
| Root cause | Radiation Control for Health and Safety Act |
| Action | A Product Safety Notification letter, dated March 3, 2008, was sent to affected customers. The letter provided information about the safety issue, identified affected product and stated that GE Healthcare will provide a software upgrade. Contact GE Healthcare at 1-262-544-3894 for assistance. |
| Quantity | 12 |
| Distribution | AL, CA, CO, FL, IL, KS, MA, ME, MN,MO, NC, NJ, NM, NY OK, SC, TN, TX, and WI. |
| FDA record | Open on fda.gov |