CLASS II Device recall · Reported 3 Jul 2013 · FDA Enforcement Report
Soma v Automated Breast Ultrasound System (ABUS) recalled by U-systems
U-systems is recalling Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound, distributed in California, Illinois. The recall was initiated on 16 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1587-2013
- FDA event ID
- 65371
- Recalling firm
- U-systems, Sunnyvale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 May 2013
- FDA classified
- 24 Jun 2013
- Reported
- 3 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 16 May 2013 | Recall initiated by company | |
| 24 Jun 2013 | Classified by FDA | +39 days |
| 3 Jul 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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].
Product as listed by the FDA
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
Where it was distributed
Distributed in California and Illinois.
Questions about this recall
Why was it 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].
Which lots are affected?
Serial numbers: H1280099, H1180094, B1380105
Where was it sold?
Distributed in California and Illinois.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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