FDA Recall
Terminated
Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250
Recall: Z-0299-03
·
Initiated January 22, 2003
Recall
- Recall Number
- Z-0299-03
- Event Number
- 25428
- Firm
- Biosound Esaote, Inc.
- FEI Number
- 1826555
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 22, 2003
- Posted
- April 3, 2003
- Terminated
- February 5, 2004
- Address
- 8000 Castleway Drive, Indianapolis, IN, 46250
Description
Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250
Reason
Excessive power output due to a faulty voltage controller.
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.
Distribution
United States and Canada
Quantity
157 Caris Plus systems, 503 Megas