Date Initiated by Firm |
January 05, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on September 10, 2004 |
Recall Number |
Z-0885-04 |
Recall Event ID |
28472 |
Product Classification |
System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
|
Product |
EZ-DOP, diagnostic ultrasound imaging system |
Code Information |
Serial numbers LDP4 0024 through LDP4 390. |
Recalling Firm/ Manufacturer |
DWL Systems, Inc. 100 Carpenter Drive Suite 202 Sterling VA 20164
|
For Additional Information Contact |
David G. Pegler 703-471-6621
|
Manufacturer Reason for Recall |
A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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