Z-0975-03

Acuson Cypress Echocardiography System. Imaging System

Name: Z-0975-03 Acuson Cypress Echocardiography System. Imaging System
Creator: Siemans Medial Solutions USA, Inc
Published: 2003-04-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2003-04-01 / Terminated / root cause: software

FDA source

Siemans Medial Solutions USA, Inc began a recall of Acuson Cypress Echocardiography System. Imaging System on 2003-04-01. The reason FDA records is "software problem - loss of data". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0975-03
Status: Terminated
Initiated: 2003-04-01
Posted: 2003-07-02
Terminated: 2004-01-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Acuson Cypress Echocardiography System. Imaging System
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: software problem - loss of data
Root cause tag: software
FDA root cause: Other
Action: The recalling firm issued a letter dated 4/03 explaining the problem and the work around. A software upgarde is being provided free of charge to the customers.
Quantity in commerce: 1540 units
Distribution: The device was shipped to hospitals and physicians nationwide. The device was also shipped to accounts in Argentina, Australia, Austria, Belgium, Boliva, Brazil, Canada, Chile, Columbia, Costa Rica, Cypress, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, South Korea, Kuwait, Luxembourg, Malaysia, Mexico, netherlands, Norway, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, and United Kingdom.
Product codes and lots: Catalog # 8264604. Serial numbers 70000 through 72000.

Product code IYN

K021497Class IICypress Ultrasound SystemAcuson Corp. / cleared 2002-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)