Z-0744-04

Acuson Cypress Echocardiography System

Name: Z-0744-04 Acuson Cypress Echocardiography System
Creator: Siemans Medial Solutions USA, Inc
Published: 2004-02-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2004-02-02 / Terminated / root cause: software

FDA source

Siemans Medial Solutions USA, Inc began a recall of Acuson Cypress Echocardiography System on 2004-02-02. The reason FDA records is "software problem - mode does not appear on screen". 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-0744-04
Status: Terminated
Initiated: 2004-02-02
Posted: 2004-07-20
Terminated: 2004-08-19
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Acuson Cypress Echocardiography System
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: software problem - mode does not appear on screen
Root cause tag: software
FDA root cause: Other
Action: The recalling firm telephoned their direct accounts to inform them of the problem and the need to modify the software. The call were made from 2/2-16/04. The modification kits were sent to consignees via express delivery.
Quantity in commerce: 46 units
Distribution: The product was shipped to physicians and medical facilities in AZ, CA, CT, FL, IA, IL, NE, NV, NY, OH, TX, and WA. The product was also shipped to Australia, Brazil, Canada, Denmark, Germany, Italy, Japan, New Zealand, South Korea, and Sweden.
Product codes and lots: Catalog number 8264604; Serial numbers 73480 through 73535, 71165, 71561, 72532, 73125, and 73292.

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)