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U.S. Department of Health and Human Services

Class 2 Device Recall TSX101: Aquilion 32/64

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 Class 2 Recall
TSX101: Aquilion 32/64
see related information
Date Posted September 16, 2011
Recall Status1 Terminated on March 18, 2013
Recall Number Z-3221-2011
Recall Event ID 59519
Premarket Notification
510(K) Number
K080211 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed.
Code Information Units manufactured from January 2005 to September 2007
Recalling Firm/
Manufacturer
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92781-2068
Manufacturer Reason
for Recall
There is the potential that the current may not be controlled correctly in examinations using the ECG modulation function, which adjusts the x-ray output in synchronization with the ECG waveform.
FDA Determined
Cause 2
DESIGN: Software Design
Action Toshiba America Medical Systems (TAMS) issued an Urgent: Medical Device Correction notification to consignees via USPS return receipt mail. The letter identified the affected product, the problem, and corrective action. The firm plans to install revised firmware to prevent the occurrence of the problem. A Toshiba Service Representative will contact customers to schedule an appointment for installation. The firm asked customers to stop using the Power Reduction option during ECG modulated scanning until the new firmware has been installed. Customers are to share the information in the letter with all users, reviewing radiologist, and the clinical engineering or Biomedical group at their facility. Customers are also to complete and return the attached reply form via fax or e-mail to TAMS as proof of notification. Questions pertaining to the letter should be directed to 800-421-1968 or customers' local Toshiba Representative at 800-521-1968.
Quantity in Commerce 528 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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