Soma v Automated Breast Ultrasound System recall
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
Why was Soma v Automated Breast Ultrasound System recalled?
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].
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers: H1280099, H1180094, B1380105
- Product
- Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
- Recalling firm
- U-systems Inc
- Quantity
- 3 units
- Distribution
- Distributed in California and Illinois.
- Recall date
- July 3, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)