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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = PAA
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PMA Database | PMAs with Product Code = PAA
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