Class 2 Device Recall Infinix8000V

• Date Initiated by Firm: March 03, 2020
• Create Date: June 09, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2325-2020
• Recall Event ID: 85309
• 510(K)Number: K170909
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
• Code Information: Serial Numbers: A5B1642006, A1B17X2004, A5A1612005, A5B1772009, B5B1962002, A3A1522004, A7B16Y2001, A3A1712011, A5B1792010, A5A1532002, A1A1612003, A3A15Z2007, A5A1552003, A5B16Y2007, A3B1862016, A3B1812013, A3A1662009, A9A16X2004, BTA1922001, A3B1842015, AOB1882001, BMB1942001, AOB1892002, A5B1472001, A5B17Z2011, A3A14X2002, A5A1592004, A3A17Z2012, A5C1832012, A5B16Z2008, A1A1582002, A9A1582002, A1A14X2001, A3A1512003, A7C1812002, ABC18X2002, A3A1592005, UTC14Y2008, A3A15X2006, B5B1942001, A3A1682010, A1C18Z2005, A9A1662003, A3A1492001, A3B1822014, A3A1622008
• Recalling Firm/ Manufacturer: Canon Medical System, USA, INC.; 2441 Michelle Dr; Tustin CA 92780-7047
• For Additional Information Contact: 714-730-5000
• Manufacturer Reason for Recall: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
• FDA Determined Cause: Process control
• Action: On 03/03/20, Urgent Medical Device Correction notices were mailed to Radiology Managers/Directors. To correct this issue, the bolts holding the longitudinal movement of the table will need to be inspected to determine if the bolts are tightened to specification. Recalling firm service representatives will contact customers to set up appointments to inspect bolts. Radiology Managers/Directors were advised of the following: a) Should this problem occur before your appointment with the recalling firm's service representative, please stop using the system and contact the service representative. b) If abnormalities are found operating the table during a procedure, please stop use, and contact the service representative. c) Share this information with all users and reviewing radiologists as well as clinical engineering, and the biomedical group at your facility. d) Complete and return the Customer Reply Form. Additional questions should be directed to (800) 421-1968 or your local service representative (800) 521-1968
• Quantity in Commerce: 46
• Distribution: US Nationwide distribution including in the states of PA, AR, OH, NC, CA, IA, GA, IL, AL, WV, LA, MO, FL, MS, TX, AZ, MA, NJ, MD, NY, NV, OK, WI, PR.
• 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