Reported Feb 9, 2022 · Ongoing

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

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. · 22010 SE 51st St · Issaquah, WA · 98029-7298

Is this the product you have?

  • ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Lot codes and dates
  • Software
  • Version VA25A/B System Serial Numbers

    1,161 of 1,161 codes

    • 800101
    • 800106
    • 800117
    • 800126
    • 800135
    • 800136
    • 800138
    • 800140
    • 800142
    • 800147
    • 800157
    • 800159
    • 800162
    • 800163
    • 800171
    • 800176
    • 800177
    • 800181
    • 800182
    • 800183
    • 800184
    • 800185
    • 800186
    • 800187
    • 800190
    • 800191
    • 800192
    • 800196
    • 800199
    • 800203
    • 800205
    • 800206
    • 800207
    • 800211
    • 800212
    • 800213
    • 800218
    • 800219
    • 800220
    • 800223
    • 800225
    • 800226
    • 800228
    • 800229
    • 800230
    • 800232
    • 800236
    • 800237
    • 800241
    • 800244
    • 800249
    • 800250
    • 800251
    • 800255
    • 800256
    • 800258
    • 800260
    • 800265
    • 800267
    • 800273
Amount recalled
1161 systems

Where it was sold

Why it was recalled

Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 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.