FDA Medical Device Recalls (openFDA)
Siemans Medial Solutions USA, Inc: Acuson Cypress Echocardiography System. Imaging System
- Recall number
- Z-0975-03
- Recalling firm
- Siemans Medial Solutions USA, Inc
- Product
- Acuson Cypress Echocardiography System. Imaging System
- Status
- Terminated
- Initiated
- 2003-04-01
- Posted
- 2003-07-02
- Terminated
- 2004-01-16
- Reason
- software problem - loss of data
- 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
- 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.
- Lot, serial or model codes
- Catalog # 8264604. Serial numbers 70000 through 72000.
- 510(k) numbers
- ["K021497"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3002626007
- Firm city
- Plymouth Meeting
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28