ACUSON SC2000 Ultrasound System. The firm name on the… recallZ-1200-2018 · Siemens Medical Solutions USA, Inc. · initiated Mar 5, 2018
Class II Terminated All recalls posted in March 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1200-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 5, 2018
- Posted by the FDA
- Mar 26, 2018
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 229 systems
- Product code
- IYN
- FDA submissions
- K170315
- 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.
Product description
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K170315 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ACUSON SC2000 Diagnostic Ultrasound System 10433816Siemens Medical Solutions USA, Inc. · System, imaging, pulsed doppler, ultrasonic14 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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