FDA Medical Device Recalls (openFDA)
Siemans Medial Solutions USA, Inc: Acuson Cypress Echocardiography System
- Recall number
- Z-0744-04
- Recalling firm
- Siemans Medial Solutions USA, Inc
- Product
- Acuson Cypress Echocardiography System
- Status
- Terminated
- Initiated
- 2004-02-02
- Posted
- 2004-07-20
- Terminated
- 2004-08-19
- Reason
- software problem - mode does not appear on screen
- 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
- 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.
- Lot, serial or model codes
- Catalog number 8264604; Serial numbers 73480 through 73535, 71165, 71561, 72532, 73125, and 73292.
- 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