Recall Z-0939-04 ยท ITY Assembly, Tube Housing, X-Ray, Diagnostic
Fischer Imaging Corporation
SenoScan True View Digital Mammography System
| Date | Jul 20, 2004 (initiated Apr 12, 2004) |
| Status | Terminated |
| Reason | X-ray tube may overheat after high usage because of mis-wired thermal switch circuit. |
| Root cause | Other |
| Action | Customers were notified by certified mail on 4/19/2004. |
| Quantity | 37 |
| Distribution | Nationwide CA, CO, FL, IN, MA, MO, NC, NY, OK, TX, WI, Mexico, France. No government or military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.