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U.S. Department of Health and Human Services

Class 2 Device Recall Soma v Automated Breast Ultrasound System

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  Class 2 Device Recall Soma v Automated Breast Ultrasound System see related information
Date Initiated by Firm May 16, 2013
Date Posted June 24, 2013
Recall Status1 Terminated 3 on November 04, 2013
Recall Number Z-1587-2013
Recall Event ID 65371
510(K)Number K080930  
PMA Number P110006 
Product Classification Automated breast ultrasound - Product Code PAA
Product Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound.

Indicated as an adjunct to mammography for breast cancer screening.
Code Information Serial numbers: H1280099, H1180094, B1380105
Recalling Firm/
Manufacturer		 U-systems Inc
447 Indio Way
Sunnyvale CA 94085-4203
For Additional Information Contact Chelsey Erickson
408-570-1323 Ext. 308
Manufacturer 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].
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 3 units
Distribution Distributed in California and Illinois.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PAA and Original Applicant = U-SYSTEM, INC.
PMA Database PMAs with Product Code = PAA and Original Applicant = U-SYSTEMS, INC.
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