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Recall Observatory FDA recall evidence

Device product

Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.

Z-1587-2013

May 16, 2013

Class II

Product summary

Firm
U-systems Inc
Event
Event 65371
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-1587-2013

Official wording

Reason: 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].

Code information: Serial numbers: H1280099, H1180094, B1380105

Distribution pattern: Distributed in California and Illinois.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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].