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Devices
Device Recall Digital mammography system.
Model / Serial
Software versions earlier than 5.2.2 Product Number 94001G-3, 105200G
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
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.
Product Description
SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G
Manufacturer
Fischer Imaging Corporation
1 Event
Recall of Device Recall Digital mammography system.
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Manufacturer
Fischer Imaging Corporation
Manufacturer Address
Fischer Imaging Corporation, 12300 North Grant Street, Denver CO 80241-3120
Source
USFDA
Language
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