Z-1701-2014 Class II Terminated
FDA device recall Z-1701-2014 was initiated by Hologic, Inc. on May 13, 2014 and is designated Class II. 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 The recall status is terminated (terminated Aug 18, 2014). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 11, 2014
- Initiation Date
- May 13, 2014
- Termination Date
- Aug 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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.
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
Distribution Pattern
Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
Code Information
Serial Numbers: 1800314 7263, 180031472, 18002023051PR
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1701-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026