Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
FDA Recall Z-1587-2013 · Posted 2013-06-24
Advertisement
Recalling FirmU-systems Inc
Recall StatusTerminated
Product CodePAA
Date Initiated2013-05-16
Date Terminated2013-11-04
Product Quantity3 units
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].
Firm 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.
Root Cause
Software design
Distribution Pattern
Distributed in California and Illinois.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement