Reported Jul 3, 2013 · Terminated
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography…
U-systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: U-systems Inc · 447 Indio Way · Sunnyvale, CA · 94085-4203
Is this the product you have?
- Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
- Lot codes and dates
- Serial numbers
H1280099H1180094B1380105
- Serial numbers
- Amount recalled
- 3 units
Where it was sold
Why it was recalled
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].
This product could cause temporary or reversible health problems — stop using it.
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