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U.S. Department of Health and Human Services

Class 2 Device Recall Infinix Interventional XRay System

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  Class 2 Device Recall Infinix Interventional XRay System see related information
Date Initiated by Firm December 08, 2020
Create Date March 17, 2021
Recall Status1 Open3, Classified
Recall Number Z-1271-2021
Recall Event ID 87322
510(K)Number K081624  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F

Catheterization Table CAT-880B
Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
Code Information Table CAT-880B Models: INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BHUP INFX-8000F/AH INFX-8000F/AH INFX-8000F/UU INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BH  Table Serial Numbers: 99E1582258 99F18Y2428 99C1482200 99E15Y2271 99F1862406 99G19Z2438 99E1662308 99E1762365 99A1337005 99F1852401 99E1612286 99E1712347 99E1712345 99C14Z2224 99E1592262 99G1972436  System Serial Numbers: AHA1582003 AHC18Y2013 AHA1482001 AHA15Y2005 AHC1862012 BHB19Z2002 AHB1662007 AHB1762010 UUB12X2034 AHC1852011 AHA1612006 AHB1712009 AHB1712008 AHA14Z2002 AHA1592004 BHB1972001 
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact Ms Terry Schultz
714-730-5000
Manufacturer Reason
for Recall		 System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
FDA Determined
Cause 2		 Component design/selection
Action On 01/12/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter via USPS return receipt mail to customers informing them that the catheterization tables may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. Additionally, the manual operation of the tabletop longitudinal or lateral movement will become heavy or hard to move due to the loosening of the bolts. Customers are instructed/informed: a. Should the table top tilt during a procedure before the bolts are replaced and secured, to ensure the safety of the patient, please move the table top to the position of the patients foot and refrain from operating the tabletop as much as possible. Please contact your service representative. b. Share this information with all users and reviewing radiologist as well as clinical engineering, and the biomedical group at their facility. c. Complete and return the attached Response Form and fax it to the toll free number 877-349-3054, or return via email to RAffairs@us.medical.canon For any questions or assistance, contact Regulatory Affairs Manager at 800-421-1968 or the local service representative at 800-521-1968.
Quantity in Commerce Total of all Systems = 145 systems (U.S.)
Distribution Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, WA, WI and WV. The countries of Canada, China, Japan, Korea, and Singapore.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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