Siemens Medical Solutions USA, Inc. recalls ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structur…

Recall date

October 7, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0182-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Worldwide Distribution -- US and Albania, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, F…

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.