Recall Z-0379-05 ยท IZH System, X-Ray, Mammographic
Fischer Imaging Corporation
MammoTest Breast Biopsy System.
| Date | Jan 5, 2005 (initiated Jul 9, 2004) |
| Status | Terminated |
| Reason | X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning. |
| Root cause | Other |
| Action | Consignees were notified by letter on 7/9/2004. |
| Quantity | 860 units |
| Distribution | Nationwide, including VA facility in AR, military facilities in CA, FL, GA, MD, MO, NC, TX. Foreign distribution to Austria, Belgium, Canada, Czech Republic, France, Germany, Greece, Italy, Norway, Poland, Portugal, Russia, Saudi Arabia, Spain, Switzerland, The Netherlands, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861692 | FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM Fischer Imaging Corp., Dec 15, 1986 |