FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
- Recall number
- Z-1200-2018
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
- Status
- Terminated
- Initiated
- 2018-03-05
- Posted
- 2018-03-26
- Terminated
- 2021-02-26
- Reason
- The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 229 systems
- Distribution
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K170315"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 2936884
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28