| Class 2 Device Recall Aquilion ONE CT System TSX301 A/2D | |
Date Initiated by Firm | February 03, 2009 |
Date Posted | September 01, 2010 |
Recall Status1 |
Terminated 3 on September 02, 2011 |
Recall Number | Z-2339-2010 |
Recall Event ID |
52830 |
510(K)Number | K072606 |
Product Classification |
System, x-ray, tomography x-ray, computed - Product Code JAK
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Product | Toshiba Aquilion ONE CT SystemTSX-301 A/2D |
Code Information |
2DA0872038, 2DA0862034, 2DA07X2008, 2DA0842023, 2DA07X2005, 2DA0882053, 2DA0882051, 2DA0862036, 2DA0882049, 2DA0882052, 2DA0842026, 2DA07Y2010, 2DA0882048, 2DA08X2061, 2DA0792004, and 2DA0792002 |
Recalling Firm/ Manufacturer |
Toshiba American Medical Systems Inc 2441 Michelle Dr P.O. Box 2068 Tustin CA 92781-2068
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For Additional Information Contact | 714-730-5000 |
Manufacturer Reason for Recall | ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB. |
FDA Determined Cause 2 | Software design |
Action | Toshiba America Medical System Inc (TAMS) sent an Urgent: Medical Device Correction dated January 14, 2009 to their consignees. The letter described the issue and provided instructions to test the device to determine if it is an affected device. If the device is affected, contact the Toshiba service representative at 800 521-1968. Consignees were requested to complete and fax a response form to Toshiba. |
Quantity in Commerce | 16 |
Distribution | Nationwide Distribution: including the states of AL, CA, FL, GA, KY, MA, MD, MT, NV, NY, OH, PA, and Puerto Rico. |
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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510(K) Database | 510(K)s with Product Code = JAK
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