Z-0885-04

EZ-DOP, diagnostic ultrasound imaging system

Name: Z-0885-04 EZ-DOP, diagnostic ultrasound imaging system
Creator: DWL Systems, Inc.
Published: 2004-01-05
License: https://open.fda.gov/license/

DWL Systems, Inc. / initiated 2004-01-05 / Terminated

FDA source

DWL Systems, Inc. began a recall of EZ-DOP, diagnostic ultrasound imaging system on 2004-01-05. The reason FDA records is "A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0885-04
Status: Terminated
Initiated: 2004-01-05
Posted: 2004-07-20
Terminated: 2004-09-10
Recalling firm: DWL Systems, Inc.
Product: EZ-DOP, diagnostic ultrasound imaging system
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power.
FDA 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 in commerce: 367 units
Distribution: Units were distributed to end users worldwide including 67 domestic consignees.
Product codes and lots: Serial numbers LDP4 0024 through LDP4 390.

Product code IYN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)