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Terminated

MyLab30CV Ultrasound Imaging System; model 9807300000.

FDA Recall Z-1401-05 · Posted 2005-08-25

Recalling FirmBiosound Esaote, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2005-05-06
Date Terminated2005-10-25
Product Quantity9

Reason for Recall

Data may be corrupted upon re-opening archived files.

Firm Action

U.S. distributors were notified via recall letter dated 5/2/05 and U.S. customers were notified via letter dated 5/6/05. Canadian customer were notified via letter dated 5/13/05 and Puerto Rico distributor and customers were ntofied on 5/9/05. The firm is installing new software in the field.

Root Cause

Other

Distribution Pattern

Nationwide, Canada and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040596ULTRASOUND IMAGING SYSTEM, MODEL 7300Esaote, S.p.A. · 2004-03-31

Official Source

View FDA Recall →

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

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