Siemens ACUSON SC2000 Ultrasound Systems Recalled for ECG Signal Interference
Siemens is recalling 229 ACUSON SC2000 ultrasound systems because electromagnetic interference from electrosurgical equipment may cause the ECG signal to flatline.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential loss of ECG monitoring signal during surgery, which is a risk-of-harm product issue where specific injuries or illnesses have not yet been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 229 ACUSON SC2000 Ultrasound Systems. The recall affects systems with 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.
The recall was initiated because the ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment. This issue could affect the monitoring capabilities of the device during surgical procedures.
The affected systems were distributed to medical facilities in Arizona, California, Connecticut, Florida, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, and Washington. Foreign distribution included Argentina, Australia, Austria, Belgium, Bosnia Herzegovina, Colombia, Croatia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, New Zealand, the Philippines, Poland, the Republic of Korea, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, the United Arab Emirates, and Vietnam. There was no military or government distribution.
The recalled product
- Product
- ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 229
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software versions VB20A
- VB20B
Distribution
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