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U.S. Department of Health and Human Services

Class 2 Device Recall TSX301B: AQUILION Premium; System, XRay, Tomography, Computed

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  Class 2 Device Recall TSX301B: AQUILION Premium; System, XRay, Tomography, Computed see related information
Date Initiated by Firm June 22, 2011
Date Posted September 13, 2011
Recall Status1 Terminated 3 on August 11, 2014
Recall Number Z-3195-2011
Recall Event ID 59690
510(K)Number K083282  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed

X-Ray Tomography
Code Information N/A
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray, Tomography, Computed, and TSX-1O1A: AQUILION 16; System, X-Ray, Tomography, Computed due to several software issues that cause the scanners to function incorr
FDA Determined
Cause 2		 Software design
Action Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 22, 2011, to all affected customers. Customers were instructed that a revised software to prevent occurrence of the problem would be installed on their system. Their Toshiba Service Representative would contact them for an appointment to install the software to their system when it became available. Customers were requested to take temporary measures until corrective measures were taken. 1) In dual scanoscopy, do not press the short key between the completion of the first scanoscopy and the start of the second scanoscopy. 2) In dual scanoscopy, do not click the (Scano Skip) button immediately before the completion of the first scanoscopy. 3) When the SplitCase function is set to ON, do not select two or more orders simultaneously from the appointment list. 4) When an image comment is to be preset by making a selection from the preset memo, do not select any image comment with more than 10 characters. Customers were asked to share the information with all users and reviewing radiologists as well as clinical engineering or Biomedical group at the facility. Customers were asked to complete and return the attached form and fax it to 877-349-3054. For any questions call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.
Quantity in Commerce 155 units total
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.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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