Z-1587-2013 Class II Terminated
FDA device recall Z-1587-2013 was initiated by U-systems Inc on May 16, 2013 and is designated Class II. Reason for recall: 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]. The recall status is terminated (terminated November 4, 2013). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2013
- Initiation Date
- May 16, 2013
- Termination Date
- November 4, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
Reason for Recall
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].
Distribution Pattern
Distributed in California and Illinois.
Code Information
Serial numbers: H1280099, H1180094, B1380105