Biosound Esaote, Inc. MyLab25 Ultrasound Imaging System; Model 9807300002. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MyLab25 Ultrasound Imaging System; Model 9807300002.
Brand
Biosound Esaote, Inc.
Lot Codes / Batch Numbers
All units using software version 3.02: Serial numbers 530-539.
Products Sold
All units using software version 3.02: Serial numbers 530-539.
Biosound Esaote, Inc. is recalling MyLab25 Ultrasound Imaging System; Model 9807300002. due to Data may be corrupted upon re-opening archived files.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Data may be corrupted upon re-opening archived files.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026