Z-0299-03

Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System...

Name: Z-0299-03 Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System...
Creator: Biosound Esaote, Inc.
Published: 2003-01-22
License: https://open.fda.gov/license/

Esaote North America, Inc / initiated 2003-01-22 / Terminated

FDA source

Biosound Esaote, Inc. began a recall of Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250 on 2003-01-22. The reason FDA records is "Excessive power output due to a faulty voltage controller". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0299-03
Status: Terminated
Initiated: 2003-01-22
Posted: 2003-04-03
Terminated: 2004-02-05
Recalling firm: Esaote North America, Inc
Product: Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250
Reason for recall: Excessive power output due to a faulty voltage controller.
FDA 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 in commerce: 157 Caris Plus systems, 503 Megas
Distribution: United States and Canada
Product codes and lots: All Caris Plus units with PA220, PA121, PA122, PA023 or PA230 probes. All Megas units with PA122 or PA023 probes.

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)