Reported May 13, 2015 · Terminated

ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound…

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 systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is
  • intended for the following applicationsCardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications
Lot codes and dates
  • Serial Numbers

    206 of 206 codes

    • 400935
    • 400140
    • 400532
    • 400580
    • 400582
    • 400592
    • 400597
    • 400635
    • 400643
    • 400652
    • 400685
    • 400686
    • 400733
    • 400737
    • 400746
    • 400752
    • 400753
    • 400771
    • 400777
    • 400784
    • 400833
    • 400919
    • 400499
    • 400896
    • 400809
    • 400296
    • 400111
    • 400319
    • 400793
    • 400699
    • 400849
    • 400816
    • 400213
    • 400212
    • 400215
    • 400251
    • 400254
    • 400407
    • 400560
    • 400670
    • 400713
    • 400722
    • 400729
    • 400730
    • 400731
    • 400734
    • 400764
    • 400766
    • 400815
    • 400920
    • 400945
    • 400149
    • 400289
    • 400341
    • 400444
    • 400510
    • 400547
    • 400562
    • 400575
    • 400732
Amount recalled
476

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

In certain situations, loss of post exercise images can occur in Stress Echo.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 6, 2015 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.