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 |
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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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