| Class 2 Device Recall Canon Aquilion Lightning, Model TSX036A | |
Date Initiated by Firm | March 25, 2019 |
Date Posted | April 10, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1719-2020 |
Recall Event ID |
84954 |
510(K)Number | K170019 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | Canon Aquilion Lightning, Model TSX-036A |
Code Information |
Canon Aquilion Lightning, TSX-036A - Serial numbers 4LC1892122, 4LC1892125, 4LC1892129, 4LC1882114, 4OC1912163, and 4OC18Y2149. |
Recalling Firm/ Manufacturer |
Canon Medical System, USA, INC. 2441 Michelle Dr Tustin CA 92780-7047
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For Additional Information Contact | Ms. Terry Schultz 714-669-1421 |
Manufacturer Reason for Recall | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur. |
FDA Determined Cause 2 | Software design |
Action | Recall letters dated 3/25/2019 were issued on 3/25/2019 via USPS return receipt mail. |
Quantity in Commerce | 6 devices |
Distribution | Distribution was made to AK, AR, CA, FL, IA, ID, IL, KS, MA, MD, MI, MN, MO, MT, NC, ND, NH, NY, OH, OK, OR, PA, TN, TX, VT, WA, WI, and WV. There was government and military distribution but no foreign 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JAK
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