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U.S. Department of Health and Human Services

Class 2 Device Recall Infinix DPi (Infinix8000F) Catheterization Table

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  Class 2 Device Recall Infinix DPi (Infinix8000F) Catheterization Table see related information
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
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
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 = MQB and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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