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U.S. Department of Health and Human Services

Class 2 Device Recall CT system

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 Class 2 Device Recall CT systemsee related information
Date Initiated by FirmDecember 11, 2013
Date PostedMarch 06, 2014
Recall Status1 Terminated 3 on October 16, 2014
Recall NumberZ-0972-2014
Recall Event ID 67227
510(K)NumberK132222 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductTSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Code Information SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018. 
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 America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.
FDA Determined
Cause 2		Other
ActionToshiba America Medical Systems, Inc. initiated this recall by sending "Urgent Medical Device Correction," letter dated December 11, 2013, informed customers of the recall by providing, the device name, serial number, problem statement, corrective action statement, and contact information. A customer reply form accompanied the recall notification letter. Strategy: The majority of the letters are sent via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. After two weeks contact will be made with each non responding location and a copy of the letter will be faxed to that location and the fax receipt will service as proof of notification. Upon release of the new part it will be assigned to a TAMS employee with instructions for implementation at each site. Each incident is assigned a unique task number and each task is tracked through to completion. In the event that a customer refuses the installation of the corrected software/hardware the customer would be requested to sign a service case record stating that the corrected software/hardware was refused. CDRH approves the CAP subject to the following condition: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. For further questions please call (714) 730-5000.
Quantity in Commerce8 units
DistributionUS Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.
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 = JAK
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