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U.S. Department of Health and Human Services

Class 2 Device Recall XARIO 200

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 Class 2 Device Recall XARIO 200see related information
Date Initiated by FirmMay 01, 2017
Create DateJuly 10, 2017
Recall Status1 Terminated 3 on October 11, 2023
Recall NumberZ-2709-2017
Recall Event ID 77599
510(K)NumberK162155 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductXARIO 200 TUS-X200 diagnostic ultrasound system
Code Information Serial Number W5B1712472
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
PO Box 2068
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionToshiba Medical sent an Urgent Medical Device Correction letter on May 1, 2017. The consignee is instructed not to use the Continuous Trace method for cardiac velocity trace measurements to quantify the MPG values. Modified software is being provided. A Toshiba service representative will contact the consignee to make an appointment to install the modified software to fix the problem. Customers were asked to complete the form and fax it to the toll-free number shown at the top of the form. The form can also be sent by email to RAffairs@tams.com. Customers with questions were instructed to call 800-521-1968.
Quantity in Commerce1 unit
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = IYN
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