FDA Medical Device Recalls (openFDA)
DWL Systems, Inc.: EZ-DOP, diagnostic ultrasound imaging system
- Recall number
- Z-0885-04
- Recalling firm
- DWL Systems, Inc.
- Product
- EZ-DOP, diagnostic ultrasound imaging system
- Status
- Terminated
- Initiated
- 2004-01-05
- Posted
- 2004-07-20
- Terminated
- 2004-09-10
- Reason
- A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power.
- Root cause
- Other
- Action
- The firm notified consignees by mail on 1/5/2004 and advised of potential for inaccurate power display when the device is actually transmitting. Consignees were requested to return the device for a software upgrade.
- Quantity
- 367 units
- Distribution
- Units were distributed to end users worldwide including 67 domestic consignees.
- Lot, serial or model codes
- Serial numbers LDP4 0024 through LDP4 390.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3003504574
- Firm city
- Sterling
- Firm state
- VA
- 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