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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-1269-2021
Recall Event ID 87322
510(K)Number K170909  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V

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-8000V/A6 INFX-8000V/AA INFX-8000V/AC INFX-8000V/A8 INFX-8000V/U7 INFX-8000V/AA INFX-8000V/U7 INFX-8000V/UF INFX-8000V/BN INFX-8000V/BU INFX-8000V/UD INFX-8000V/UL INFX-8000V/A6 INFX-8000V/AC INFX-8000V/AA INFX-8000V/UU INFX-8000V/A6 INFX-8000V/U5 INFX-8000V/BAUP INFX-8000V/A2 INFX-8000V/A2 INFX-8000V/A4 INFX-8000V/UL INFX-8000V/UL INFX-8000V/UL INFX-8000V/A4 INFX-8000V/BG INFX-8000V/BG INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AA INFX-8000V/AA INFX-8000V/AA INFX-8000V/BQ INFX-8000V/UU INFX-8000V/BL INFX-8000V/BL INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/AC INFX-8000V/BL INFX-8000V/UF INFX-8000V/UF INFX-8000V/BY INFX-8000V/BS INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AC INFX-8000V/UF INFX-8000V/UF INFX-8000V/B6 INFX-8000V/UF INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/U7 INFX-8000V/UU INFX-8000V/UD INFX-8000V/BC INFX-8000V/UU INFX-8000V/BG INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A4 INFX-8000V/UL INFX-8000V/A8/VL63-2015B/A INFX-8000V/AA INFX-8000V/A8 INFX-8000V/A4 INFX-8000V/BY INFX-8000V/BY INFX-8000V/UF INFX-8000V/AA INFX-8000V/A8 INFX-8000V/A4 INFX-8000V/AA INFX-8000V/A6 INFX-8000V/B2 INFX-8000V/BU INFX-8000V/UU INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/UU INFX-8000V/BQ  Table Serial Numbers: 99E15X2267 99E1692317 99C1472192 99E16Y2329 99A12X2107 99E1542248 99C1462190 99C1442183 B1B19Y2043 B1A1942008 99A1292104 99A1322127 99E15Y2275 99C1492204 99C1492205 99A12Z2117 99E1742358 99A1272094 B1C2012053 99F18X2427 99F1952435 99D1522239 99A12Z2118 99C1392151 99C1452189 99F1862408 B1B1962022 B1B1962021 99E1652304 99F1862407 99E17X2373 99E17X2374 99E17X2375 B1B1962023 99A12X2108 B1C2022054 B1B1992039 99E16X2328 99E1622292 99E16Y2338 B1A1952015 99A12X2109 99C1452184 B1B1992038 B1C2052064 99C14Z2230 99F1882417 99E1622293 99C13X2156 99C13X2155 B1C2072071 99B1362141 99F1862403 99H2032441 99E17Z2380 99A1322125 99C13Z2167 99A1322123 B1B19X2041 99A12X2106 B1C2072073 99E16Y2336 99E1612287 99C14X2207 99C1452185 99E17Z2382 99F1842398 99E1532243 99C14Z2232 B1A1932006 B1A1932004 99A12Z2116 99E1712346 99E17X2372 99C1512236 99C14X2206 99E1582261 B1B1962020 B1B1982033 99C1452186 99F1862402 99F1862405 99E16Z2340 99A1312120 B1C2082075  System Serial Numbers: A6A15X2003 AAA1692006 ACA1472001 A8B16Y2002 U7D12X2007 A9A1542001 U7E1462009 UFD1442017 BNB19Y2001 BUB1942001 UDA0952001 ULC1322012 A6A15Y2004 ACA1492002 AAA1492001 UUB12Z2009 A6B1742011 U5E1272003 BAD2012001 A2C18X2001 A2C1952002 A4A1522004 ULC1282010 ULD1392013 ULD1452016 A4B1862007 BGB1962002 BGB1962001 A6B1652007 AAB1862012 AAA17X2008 AAA17X2009 AAA17X2010 BQB1962001 UUB12X2008 BLD2022003 BLB1992002 A6B16X2008 A6B1622006 ACB16Y2004 BLB1952001 UFC12X2011 UFD1452018 BYB1992003 BSD2052001 A6A14Z2001 AAB1882013 ACB1622003 UFD13X2016 UFD13X2015 B6D2072001 UFD1362014 A6C1862014 A6C2032016 A6B17Z2012 U7D1322008 UUC13Z2011 UDD1322016 BCB19X2001 UUB12X2007 BGD2072003 A6B16Y2009 A6A1612005 A4A14X2001 ULD1452015 A8B17Z2004 AAB1842011 A8A1532001 A4A14Z2002 BYA1932002 BYA1932001 UFC12Z2013 AAA1712007 A8B17X2003 A4A1512003 AAA14X2002 A6A1582002 B2B1962001 BUB1982002 UUC1452012 A6C1862013 A6C1862015 A6B16Z2010 UUB1312010 BQD2082002  
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 Coroporation
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