SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G
This recall has been terminated (originally issued April 11, 2006).
- Company
- Fischer Imaging Corporation
- Recall Initiated
- March 27, 2006
- Posted
- April 11, 2006
- Terminated
- March 13, 2012
- Recall Number
- Z-0757-06
- Quantity
- 80 units.(Domestic) Foreign list pending
- Firm Location
- Denver, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Software upgrade to preclude lost images during mammography procedure.
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.
Lot / Code Info
Software versions earlier than 5.2.2 Product Number 94001G-3, 105200G
Root Cause
Other
Action Taken
Consignees were notified by letter on 03/27/2006.
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