Class 2 Device Recall Caris Plus

• Date Initiated by Firm: January 22, 2003
• Date Posted: April 03, 2003
• Recall Status: Terminated on February 05, 2004
• Recall Number: Z-0299-03
• Recall Event ID: 25428
• Product: Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250
• Code Information: All Caris Plus units with PA220, PA121, PA122, PA023 or PA230 probes. All Megas units with PA122 or PA023 probes.
• Recalling Firm/ Manufacturer: Biosound Esaote, Inc.; 8000 Castleway Drive; Indianapolis IN 46250
• For Additional Information Contact: Thomas B. Feick; 317-813-6006
• Manufacturer Reason for Recall: Excessive power output due to a faulty voltage controller.
• FDA Determined 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

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.