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U.S. Department of Health and Human Services

Class 3 Device Recall EZDOP

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  Class 3 Device Recall EZDOP see related information
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/
DWL Systems, Inc.
100 Carpenter Drive
Suite 202
Sterling VA 20164
For Additional Information Contact David G. Pegler
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
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

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.