FDAOctober 7, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
siemens medical solutionssiemenssiemens medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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