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Terminated

Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.

FDA Recall Z-2542-2016 · Posted None

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeIYN
Date Initiated2016-08-04
Date Terminated2017-11-17
Product Quantity93 units

Reason for Recall

Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.

Firm Action

An Urgent Medical Device Correction letter was sent to all customers to bring to attention a potential problem of transducer heating with your Xario Ultrasound System. The letter informs the customers that the surface of the acoustic lens of a transducer may become hot because of a software error. The error occurs when a transducer is disconnected, reconnected, or another transducer is selected. The letter informs the customers of error message and the corrective action. Customers are instructed to complete the attached form and fax it to (877) 349-3054 or [email protected]. Customer with any questions are instructed to call (714) 730-5000 or their Toshiba service representative at (800) 521-1968.

Root Cause

Software design

Distribution Pattern

US Distribution

Official Source

View FDA Recall →

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

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