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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79568

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 05, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1200-2018
Recall number
Z-1200-2018
Initiated
March 05, 2018
Classification
Class II
Status
Terminated
Quantity
229 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Field note

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