FDAFDA · Food and drugs·Recall number Z-1701-2014
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
Published June 11, 2014 · Recall initiated: May 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hologic, Inc.
- Distributor
- Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
- Lot
- Serial Numbers: 1800314 7263, 180031472, 18002023051PR
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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