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Recall Observatory FDA recall evidence

Device product

ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.

Z-1200-2018

March 05, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc.
Event
Event 79568
Status
Terminated
Classification
Class II
Quantity
229 systems
Official record key
device-enforcement:Z-1200-2018

Official wording

Reason: The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.