Siemens recalls ACUSON SC2000 ultrasound systems with specific software versions that may cause ECG signal flatline during electrosurgical use. Affected units have Siemens Medical Solutions USA, Inc. label and specific software revisions.
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Siemens is recalling ACUSON SC2000 ultrasound systems with software versions VB20A, VB20B, or VB20C that have a common physio module installed at revision 4. This could cause the ECG signal to flatline when using electrosurgical equipment, potentially leading to medical risks during procedures.
The ECG signal may flatline due to electromagnetic interference when electrosurgical equipment is used. This could disrupt the ultrasound system's ability to monitor heart activity, potentially causing serious medical issues during surgery.
Medical professionals using the ACUSON SC2000 ultrasound system with the specified software versions are most at risk during electrosurgical procedures. Patients undergoing surgery with this equipment may also be affected.
Check for the Siemens Medical Solutions USA, Inc. label on the device. Affected units have software versions VB20A, VB20B, or VB20C with a common physio module installed at revision 4.
Identify the software version on your ACUSON SC2000 system to see if it is VB20A, VB20B, or VB20C with a common physio module installed at revision 4.
Software versions VB20A, VB20B, or VB20C with a common physio module (CPM) installed at revision 4.
Check for the Siemens Medical Solutions USA, Inc. label and software versions VB20A, VB20B, or VB20C with a common physio module installed at revision 4.
The recall does not specify a remedy, so contact Siemens directly for guidance.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1200-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1200-2018 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.