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Terminated

GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA.

FDA Recall Z-0113-2008 · Posted 2007-11-07

Recalling FirmGe Healthcare
Recall StatusTerminated
Product CodeIYO
Date Initiated2007-07-06
Date Terminated2008-10-21
Product Quantity521 Units

Reason for Recall

When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.

Firm Action

GE Healthcare sent customer letters on July 15, 2007 to affected customers. The letter included a short term mitigation recommendation and a long-term correction. The long-term correction will be software upgrade provided free of charge to all affected customers.

Root Cause

Software design

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061682GE VOLUSON E8 ULTRASOUND SYSTEMGeneral Electric Co. · 2006-07-12

Official Source

View FDA Recall →

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

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