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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

Product Description Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
Recall Number Z-0119-2014
Classification Class II
Code Info Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613
Product Distributed Qty 17 (1352 Total)
Reason For Recall The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode.

Event Detail

Event Id 66059
Product Type Devices
Status Ongoing
Recalling Firm Toshiba American Medical Systems Inc
City Tustin
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including and US Territory Puerto Rico