Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
FDA Recall Z-1701-2014 · Posted 2014-06-03
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Recalling FirmHologic, Inc.
Recall StatusTerminated
Product CodeIZH
Date Initiated2014-05-13
Date Terminated2014-08-18
Product Quantity3 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
Firm Action
Hologic notified customers by letter dated 5/13/14 via certified mail or Federal Express to inform customers of the problem and provide acknowledgement of the notification and confirmation that their systems have been corrected
A Dealer notification dated 5/13/14 sent by certified mail or Federal Express to inform Dealers of the need to notify their customers of the problem and to correct the identified Selenia system using Hologic Technical Bulletin TB-00806. On 5/16/14 the firm expanded the recall to an additional units Mammography System M-IV (2 units) and Selenia Mammography Systems (4) by letter dated 5/14/14.
If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.
Root Cause
Component change control
Distribution Pattern
Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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