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U.S. Department of Health and Human Services

Class 2 Device Recall Aplio 500/400/300 Diagnostic Ultrasound System

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  Class 2 Device Recall Aplio 500/400/300 Diagnostic Ultrasound System see related information
Date Initiated by Firm December 11, 2012
Date Posted April 12, 2013
Recall Status1 Terminated 3 on April 10, 2014
Recall Number Z-1104-2013
Recall Event ID 64693
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300).
Device Listing Number: Dl53118.

Diagnostic Ultrasound system.
Code Information Item numbers: TUS-A300/Wl and TUS-A500/Wl 
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.
FDA Determined
Cause 2		 Device Design
Action Toshiba sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated December 11, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (800) 421-1968 for questions regarding this letter.
Quantity in Commerce 233 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC 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.
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