Device product
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
Z-1701-2014
Product summary
- Firm
- Hologic, Inc.
- Event
- Event 68298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1701-2014
Official wording
Reason: 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
Code information: Serial Numbers: 1800314 7263, 180031472, 18002023051PR
Distribution pattern: Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Derived failure modes
-
Unknown
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