Recall Z-0757-06 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Fischer Imaging Corporation
SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G
| Date | Apr 11, 2006 (initiated Mar 27, 2006) |
| Status | Terminated |
| Reason | Software upgrade to preclude lost images during mammography procedure. |
| Root cause | Other |
| Action | Consignees were notified by letter on 03/27/2006. |
| Quantity | 80 units.(Domestic) Foreign list pending |
| Distribution | Nationwide. AZ, CA, CO, FL, GA, IL, IN, KS, MA, MI, MN, MT, NY, OK, SC, TX, WA, WI, WV. No government or military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.