Reported Apr 7, 2021 · Ongoing

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual…

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?

  • Product Label - ACUSON Sequoia ***
  • Power Input100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
Lot codes and dates
  • Model11148775 Equipment Serial Numbers (U.S.)

    614 of 614 codes

    • 800015
    • 800101
    • 800103
    • 800104
    • 800105
    • 800106
    • 800107
    • 800108
    • 800109
    • 800111
    • 800112
    • 800113
    • 800116
    • 800118
    • 800119
    • 800121
    • 800134
    • 800138
    • 800139
    • 800141
    • 800142
    • 800143
    • 800149
    • 800150
    • 800151
    • 800152
    • 800153
    • 800155
    • 800157
    • 800158
    • 800161
    • 800165
    • 800168
    • 800172
    • 800174
    • 800175
    • 800176
    • 800177
    • 800178
    • 800182
    • 800183
    • 800184
    • 800185
    • 800186
    • 800189
    • 800190
    • 800191
    • 800192
    • 800193
    • 800194
    • 800195
    • 800196
    • 800198
    • 800199
    • 800201
    • 800203
    • 800204
    • 800205
    • 800208
    • 800209
    Equipment Serial Numbers (O.U.S.):

    558 of 558 codes

    • 800344
    • 800438
    • 800932
    • 801787
    • 801851
    • 801020
    • 801927
    • 801982
    • 801988
    • 802069
    • 802073
    • 802078
    • 802079
    • 802081
    • 802083
    • 802084
    • 802086
    • 802123
    • 802131
    • 802135
    • 802140
    • 802147
    • 802180
    • 802181
    • 802183
    • 802185
    • 802186
    • 802187
    • 802188
    • 802189
    • 800114
    • 800115
    • 800117
    • 800120
    • 800122
    • 800123
    • 800126
    • 800127
    • 800129
    • 800130
    • 800133
    • 800135
    • 800136
    • 800140
    • 800147
    • 800148
    • 800159
    • 800162
    • 800163
    • 800166
    • 800167
    • 800169
    • 800170
    • 800171
    • 800181
    • 800187
    • 800197
    • 800206
    • 800207
    • 800212
Amount recalled
1,172 systems

Where it was sold

Why it was recalled

The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.

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, 6:20 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.