Recall Z-1587-2013 ยท PAA Automated Breast Ultrasound
U-systems Inc
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
| Date | Jun 24, 2013 (initiated May 16, 2013) |
| Status | Terminated |
| 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]. |
| Root cause | 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 | 3 units |
| Distribution | Distributed in California and Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080930 | MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS U-System, Inc., Aug 7, 2008 |