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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast. Serial Numbers: 1800314 7263, 180031472, 18002023051PR Class II 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 3 units Z-1701-2014
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W Class II 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 11 units Z-1700-2014
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