SenoScan True View Digital Mammography System
This recall has been terminated (originally issued July 20, 2004).
- Company
- Fischer Imaging Corporation
- Recall Initiated
- April 12, 2004
- Posted
- July 20, 2004
- Terminated
- July 26, 2004
- Recall Number
- Z-0939-04
- Quantity
- 37
- Firm Location
- Denver, CO
- Official Source
- View on FDA website ↗
Reason for Recall
X-ray tube may overheat after high usage because of mis-wired thermal switch circuit.
Distribution
Nationwide CA, CO, FL, IN, MA, MO, NC, NY, OK, TX, WI, Mexico, France. No government or military distribution.
Lot / Code Info
Serial Numbers: 9800-0103-001, 9800-0104-001, 0900-0104-002, 9800-0104-003, 9800-0203-001, 9800-0204-001, 9800-0204-002, 9800-0204-004, 9800-0204-005, 9800-0303-003, 9800-0402-003, 9800 0403-001, 9800-0502-001, 9800-0602-001R, 9800-0603-001, 9800-0603-002, 9800-0901-001R, 9800-0903-001, 9800-1001-001, 9800-1003-003, 9800-1003-004, 9800-1102-003, 9800-1102-007, 9800-1103-001, 9800-1103-002, 9800-1103-003, 9800-1103-004, 9800-1103-005, 9800-1103-006, 9800-1103-007, 9800-1103-008, 9800-1103-009, 9800-1103-011, 9800-1103-012, 9800-1202-003, 9800-1203-001, 9800-1203-002.
Root Cause
Other
Action Taken
Customers were notified by certified mail on 4/19/2004.