—#133279

Product

ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.

FDA product code: IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K081148
Affected lot / code info: Serial numbers 250157-250190.

Why it was recalled

There is a low probability the scanner arm will become completely detached from the scanner column.

Root cause (FDA determination)

Vendor change control

Action the firm took

Siemens sent a Customer Safety Advisory Notification to all affected sites on January 12, 2015, certified mail, with return receipt. The letter identified the affected product, the issue, and potential risk. Customers were asked to immediately discontinue use of the affected product. A Customer Service Engineer will contact customers to schedule an appointment to make the necessary repairs. Questions should be directed to a local service support person for information regarding timelines and status. Customers are to share the information with all personnel, who need to be aware of the issue.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 685 E Middlefield Rd, Mountain View, California 94043-4045

Distribution

Distribution pattern: Worldwide Distribution -- US, including the states of TX and MN, and the territory of P.R.; and, the countries of China, Germany, Russian Fed, Saudi Arabia, Taiwan, France, Thailand, and Italy.

Timeline

Recall initiated: 2015-01-12
Posted by FDA: 2015-02-07
Terminated: 2015-06-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133279. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.