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Terminated

EZ-DOP, diagnostic ultrasound imaging system

FDA Recall Z-0885-04 · Posted 2004-07-20

Recalling FirmDWL Systems, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2004-01-05
Date Terminated2004-09-10
Product Quantity367 units

Reason for Recall

A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power.

Firm 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.

Root Cause

Other

Distribution Pattern

Units were distributed to end users worldwide including 67 domestic consignees.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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