Siemens brand ACUSON S2000 Ultrasound System with software versions: VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Business Unit, Mountain View, CA The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.
FDA Recall Z-1900-2011 · Posted 2011-04-06
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2009-01-14
Date Terminated2011-04-06
Reason for Recall
The product has a software problem in which previous patient measurement data gets associated with another patient's image.
Firm Action
The firm, SIEMENS, issued a "CUSTOMER SAFETY ADVISORY NOTIFICATION" letter to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that the first image in Exam Review is from the current patient; ensure that the Heart Cycle measurement tool is not selected on the Cale menu when entering Exam Review; be aware of this issue as described in the letter and perform four (4) or less measurements of the same measurement label.
Should you have any questions, please call (650) 694-5398.
Root Cause
Software change control
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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