FDA Medical Device Recalls (openFDA)
Biosound Esaote, Inc.: Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250
- Recall number
- Z-0299-03
- Recalling firm
- Biosound Esaote, Inc.
- Product
- Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250
- Status
- Terminated
- Initiated
- 2003-01-22
- Posted
- 2003-04-03
- Terminated
- 2004-02-05
- Reason
- Excessive power output due to a faulty voltage controller.
- Root cause
- Other
- Action
- This is a professional use device, and service upgrade notices were issued to customers on or about 1/22/03 informing them that the firm will be contacted by a service representative to schedule a software upgrade.
- Quantity
- 157 Caris Plus systems, 503 Megas
- Distribution
- United States and Canada
- Lot, serial or model codes
- All Caris Plus units with PA220, PA121, PA122, PA023 or PA230 probes. All Megas units with PA122 or PA023 probes.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- 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