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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-1270-2021
Recall Event ID 87322
510(K)Number K152697  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C

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-8000C/B6 INFX-8000C/B6 INFX-8000C/B4UP INFX-8000C/B4 INFX-8000C/UP INFX-8000C/UE INFX-8000C/U5 INFX-8000C/B4 INFX-8000C/A6 INFX-8000C/B6 INFX-8000C/A6 INFX-8000C/A6 INFX-8000C/A6 INFX-8000C/UP INFX-8000C/A6 INFX-8000C/UP INFX-8000C/AF INFX-8000C/A6 INFX-8000C/BF INFX-8000C/A4 INFX-8000C/UE INFX-8000C/A2 INFX-8000C/A6 INFX-8000C/UP INFX-8000C/A6 INFX-8000C/UE INFX-8000C/UE INFX-8000C/UC INFX-8000C/AF INFX-8000C/AF INFX-8000C/A6 INFX-8000C/A6 INFX-8000C/AF/VL72-2015B INFX-8000C/AF INFX-8000C/BF INFX-8000C/B2 INFX-8000C/BF INFX-8000C/B4 INFX-8000C/BF INFX-8000C/BF INFX-8000C/BF INFX-8000C/BF INFX-8000C/A6 INFX-8000C/A4 INFX-8000C/BF  Table Serial Number: B1C2072072 B1C2072070 B1C2032061 B1B19Z2048 99A1332131 99B1352138 99A1292103 B1B19X2040 99F1872415 B1A1942012 99E16X2327 99F1872409 99E1542247 99B1372146 99C1472196 99B1352139 99F1832396 99E1582259 B1A1932005 99C1472199 99A1312122 99F1812388 99F1872414 99B1342135 99E1682315 99B1342133 99B1342134 99A1332130 99F1872413 99f1872411 99F1852400 99E1742355 99E1662307 99F1892424 CTC18Y2004 B1B1972026 B1B1972029 B1B19Z2046 B1C2062066 B1A1952017 B1B1972025 B1A1942009 99C1492202 99C13Z2171 B1C2012051  System Serial Numbers: B6C2072003 B6C2072002 B4C2032004 B4B19Z2003 UPA1332003 UEB1352004 U5C1292001 B4B19X2001 A6C1872011 B6B1942001 A6B16X2006 A6C1872009 A6B1532003 UPB1372006 U6A1472001 UPB1352005 AFB1832003 A6B1582004 BFA1932001 A4B1472002 UEA1312001 A2C1812002 A6C1872010 UPB1342004 A6B1682005 UEB1347001 UEB1347002 UCA1022004 AFB1872005 AFB1872004 A6C1852008 A6B1742007 AFA1662001 AFB1892006 BFA18Y7001 B2B1972001 BFB1972005 B4B19Z2002 BFC2062007 BFB1952003 BFB1972004 BFB1942002 A6A1492002 A4A13Z2001 TEMPPM007995 
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 = OWB and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION
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