Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased
FDA device recall Z-0299-03 · posted 2003-04-03 · Terminated
Recall details
- Recalling firm
- Biosound Esaote, Inc.
- Reason for recall
- Excessive power output due to a faulty voltage controller.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 157 Caris Plus systems, 503 Megas
- Distribution
- United States and Canada
- Date initiated
- 2003-01-22
- Date posted
- 2003-04-03
- Date terminated
- 2004-02-05
- Location
- Indianapolis, IN
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