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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 EZDOPsee related information
Date Initiated by FirmJanuary 05, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on September 10, 2004
Recall NumberZ-0885-04
Recall Event ID 28472
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
ProductEZ-DOP, diagnostic ultrasound imaging system
Code Information Serial numbers LDP4 0024 through LDP4 390.
FEI Number 3003504574
Recalling Firm/
Manufacturer		 DWL Systems, Inc.
100 Carpenter Drive
Suite 202
Sterling VA 20164
For Additional Information ContactDavid 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
ActionThe 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 Commerce367 units
DistributionUnits were distributed to end users worldwide including 67 domestic consignees.
Total Product Life CycleTPLC 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.
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