Reported Nov 4, 2015 · Terminated

ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical…

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 model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.
Lot codes and dates
  • Serial Numbers

    2,097 of 2,097 codes

    • 400217
    • 400290
    • 400425
    • 400439
    • 400441
    • 400443
    • 400447
    • 401496
    • 401719
    • 402310
    • 402495
    • 400308
    • 400641
    • 400770
    • 401110
    • 401114
    • 401135
    • 401136
    • 401138
    • 401169
    • 401174
    • 401176
    • 401366
    • 401370
    • 401406
    • 401460
    • 401591
    • 401750
    • 401793
    • 401803
    • 402090
    • 402139
    • 402177
    • 402197
    • 402255
    • 402323
    • 402327
    • 402339
    • 402351
    • 402387
    • 402492
    • 402508
    • 402562
    • 402566
    • 400063
    • 400066
    • 400090
    • 400261
    • 400350
    • 400763
    • 400787
    • 400789
    • 400790
    • 400791
    • 400792
    • 400794
    • 400797
    • 400881
    • 400886
    • 400888
    401817, and 402441
Amount recalled
2,099 units

Where it was sold

Why it was recalled

Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situations where the metal component used to engage the wheel lock becomes disconnected, and where the system locks up due to misalignment between the bezel and MPI board, in all units that have not already been corrected.

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 Oct 19, 2017 · Data as of Sep 19, 6:00 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.