—#80551

Product

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 product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K082142
Affected lot / code info: All units of this model.

Why it was recalled

The product has a software problem in which previous patient measurement data gets associated with another patient's image.

Root cause (FDA determination)

Software change control

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebird Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2009-01-14
Posted by FDA: 2011-04-06
Terminated: 2011-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80551. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.