Recalls / —

—#162658

Product

ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.

FDA product code

IYN — System, Imaging, Pulsed Doppler, Ultrasonic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K170315

Affected lot / code info

Software versions VB20A, VB20B, or VB20C that have a common physio module (CPM) (known by customers as the ECG (physio) hardware) installed at revision 4

Why it was recalled

The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.

Root cause (FDA determination)

Device Design

Action the firm took

Undated recall letters were issued via email (if they had an email address for the customer) or via certified mail (if no email address was available) on 3/5/2018.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc.

Address

685 E Middlefield Rd, Mountain View, California 94043-4045

Distribution

Distribution pattern

Distribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA. There was no military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Bosnia Herzeg, Colombia, Croatia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Philippines, Poland, Republic Korea, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, and Vietnam.

Timeline

Recall initiated

2018-03-05

Posted by FDA

2018-03-26

Terminated

2021-02-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #162658. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.