Recall Z-0885-04 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
DWL Systems, Inc.
EZ-DOP, diagnostic ultrasound imaging system
| Date | Jul 20, 2004 (initiated Jan 5, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.