FDAFDA · Food and drugs·Recall number Z-1587-2013
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
Published July 3, 2013 · Recall initiated: May 16, 2013
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
Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- U-systems Inc
- Distributor
- Distributed in California and Illinois.
- Lot
- Serial numbers: H1280099, H1180094, B1380105
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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