Date Initiated by Firm | February 08, 2019 |
Create Date | November 12, 2019 |
Recall Status1 |
Terminated 3 on June 07, 2022 |
Recall Number | Z-0360-2020 |
Recall Event ID |
84135 |
510(K)Number | K081624 |
Product Classification |
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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Product | Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography. |
Code Information |
Model CAT-870B D053991 Serial No. Manufacture Date 99D08X2101 October 2008 99D0582039 August 2005 99D0762072 June 2007 99D0852090 May 2008 99D07Y2078 November 2007 99D0812081 January 2008 99D0582042 August 2005 99D0552033 May 2005 D551206 May 2005 |
Recalling Firm/ Manufacturer |
Canon Medical System, USA, INC. 2441 Michelle Dr Tustin CA 92780-7047
|
For Additional Information Contact | Terry Schultz 714-669-4121 |
Manufacturer Reason for Recall | Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit. |
FDA Determined Cause 2 | Error in labeling |
Action | On 02/08/2019, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification to customers via USPS return receipt mail informing them of the potential problem with the Catheterization Table (CAT-870B) may tilt without operator involvement due to accidental liquid spillage. Customers are instructed to:
a. Please keep the tableside console and the x-ray detector of the support units covered with sterile caps as stated in the Caution section of the operation manual. The caps are there to prevent liquids from coming into contact with the tableside console and the x-ray detector.
b. If an actual event occurs, please push the emergency switch and call your service representative.
c. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility.
d. Please complete and return the attached form and fax it to the toll free number 877-349-3054. This form may also be sent via email to RAffairs@us.medical.canon.
If customers have any questions regarding this letter, they are free to contact Regulatory Affairs Manager at (800) 421-1968 or their local
Representative at (800) 521-1968. |
Quantity in Commerce | 9 systems |
Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands. |
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 = MQB
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