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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
Recall Number Z-1701-2014
Classification Class II
Code Info Serial Numbers: 1800314 7263, 180031472, 18002023051PR
Product Distributed Qty 3 units
Reason For Recall 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

Event Detail

Event Id 68298
Product Type Devices
Status Ongoing
Recalling Firm Hologic, Inc.
City Danbury
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.