Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 11/4/2015
Class lI:
PRODUCT
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.Recall Number Z-0182-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Mountainview, CA on 10/7/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
2,099 units
DISTRIBUTION
Nationwide and Internationally
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