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Terminated

Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250

FDA Recall Z-0299-03 · Posted 2003-04-03

Recalling FirmBiosound Esaote, Inc.
Recall StatusTerminated
Date Initiated2003-01-22
Date Terminated2004-02-05
Product Quantity157 Caris Plus systems, 503 Megas

Reason for Recall

Excessive power output due to a faulty voltage controller.

Firm 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.

Root Cause

Other

Distribution Pattern

United States and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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