FDA-Device2014-06-11Class II
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
Hologic, Inc.
Hazard
Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
Sold states
Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Affected count
3 units
Manufactured in
36 Apple Ridge Rd # 37, Danbury, CT, United States
Products
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1701-2014Don't want to check this manually?
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