FDA Medical Device Recalls (openFDA)
Biosound Esaote, Inc.: MyLab25 Ultrasound Imaging System; Model 9807300002.
- Recall number
- Z-1403-05
- Recalling firm
- Biosound Esaote, Inc.
- Product
- MyLab25 Ultrasound Imaging System; Model 9807300002.
- Status
- Terminated
- Initiated
- 2005-05-06
- Posted
- 2005-08-25
- Terminated
- 2005-10-25
- Reason
- Data may be corrupted upon re-opening archived files.
- 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
- 10
- Distribution
- Nationwide, Canada and Venezuela.
- Lot, serial or model codes
- All units using software version 3.02: Serial numbers 530-539.
- 510(k) numbers
- ["K040596"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 1826555
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28