Reported May 16, 2018 · Terminated
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 685 E Middlefield Rd · Mountain View, CA · 94043-4045
Is this the product you have?
- ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
- Lot codes and dates
- 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
- Amount recalled
- 229 systems
Where it was sold
Why it was recalled
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
This product could cause temporary or reversible health problems — stop using it.
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