Cl II ACUSON S Family Ultrasound Systems

Company Siemens Medical Solutions USA, Inc
Date of Enforcement Report 7/9/2014
Class lI:

PRODUCT

ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems. Recall Number Z-1962-2014

REASON
There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA on 6/3/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
790 units

DISTRIBUTION
Nationwide and Internationally

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