MyLab30CV Ultrasound Imaging System; model 9807300001.
FDA Recall Z-1402-05 · Posted 2005-08-25
Recalling FirmBiosound Esaote, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2005-05-06
Date Terminated2005-10-25
Product Quantity176
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.