Events

Recall of Device Recall Soma v Automated Breast Ultrasound System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by U-systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65371
  • Event Risk Class
    Class 2
  • Event Number
    Z-1587-2013
  • Event Initiated Date
    2013-05-16
  • Event Date Posted
    2013-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118703
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated breast ultrasound - Product Code PAA
  • 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].
  • Action
    On 6/5/13, an "URGENT MEDICAL DEVICE CORRECTION" letter was distributed to all affected users, with a description of the problem and user corrective action steps. One consignee received an Urgent Notice to Customer - Medical Device Correction letter on 5/16/13. Contact the firm at 408-328-7925 for questions regarding this notice.

Device

Device Recall Soma v Automated Breast Ultrasound System
  • Model / Serial
    Serial numbers: H1280099, H1180094, B1380105
  • Product Classification
    Radiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Distributed in California and Illinois.
  • Product Description
    Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. || Indicated as an adjunct to mammography for breast cancer screening.
  • Manufacturer
    U-systems Inc

Manufacturer

U-systems Inc
  • Manufacturer Address
    U-systems Inc, 447 Indio Way, Sunnyvale CA 94085-4203
  • Source
    USFDA