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 Numbers401817, and 402441
2,097 of 2,097 codes
400217400290400425400439400441400443400447401496401719402310402495400308400641400770401110401114401135401136401138401169401174401176401366401370401406401460401591401750401793401803402090402139402177402197402255402323402327402339402351402387402492402508402562402566400063400066400090400261400350400763400787400789400790400791400792400794400797400881400886400888
- Serial Numbers
- 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.
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