Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography fo
FDA device recall Z-1587-2013 · posted 2013-06-24 · Terminated
Recall details
- Recalling firm
- U-systems Inc
- 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].
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- PAA
- Quantity affected
- 3 units
- Distribution
- Distributed in California and Illinois.
- Date initiated
- 2013-05-16
- Date posted
- 2013-06-24
- Date terminated
- 2013-11-04
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS (K080930) | U-System, Inc. | 2008-08-07 |