Z-1403-05

MyLab25 Ultrasound Imaging System; Model 9807300002

Name: Z-1403-05 MyLab25 Ultrasound Imaging System; Model 9807300002
Creator: Biosound Esaote, Inc.
Published: 2005-05-06
License: https://open.fda.gov/license/

Esaote North America, Inc / initiated 2005-05-06 / Terminated

FDA source

Biosound Esaote, Inc. began a recall of MyLab25 Ultrasound Imaging System; Model 9807300002 on 2005-05-06. The reason FDA records is "Data may be corrupted upon re-opening archived files". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1403-05
Status: Terminated
Initiated: 2005-05-06
Posted: 2005-08-25
Terminated: 2005-10-25
Recalling firm: Esaote North America, Inc
Product: MyLab25 Ultrasound Imaging System; Model 9807300002.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Data may be corrupted upon re-opening archived files.
FDA root cause: Other
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.
Quantity in commerce: 10
Distribution: Nationwide, Canada and Venezuela.
Product codes and lots: All units using software version 3.02: Serial numbers 530-539.

Product code IYN

K040596Class IIUltrasound Imaging System, Model 7300Esaote, S.p.A. / cleared 2004-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)