Class 2 Device Recall INFX8000C, V6.20; Alphenix, INFX8000C/B, V8.0

• Date Initiated by Firm: October 08, 2020
• Create Date: December 03, 2020
• Recall Status: Terminated on December 06, 2022
• Recall Number: Z-0532-2021
• Recall Event ID: 86650
• 510(K)Number: K152697 K181804
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - 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: Affected Serial Numbers: 1 AFA1662001, 2 AFB1872005, 3 AFB1832003, 4 AFB1872004, 5 AFB1892006, 6 BFA18Y7001, 7 AEA17X2001, 8 AFA1692002, 9 AEB1812002, 10 BFA1932001, 11 BFB1952003, 12 BFB1942002, 13 BFB1972004, 14 BFB1972005, 15 AFB1892007, 16 BEC2032001, 17 BFC2062007, 18 BFC2062008, 19 BHA1992001, 20 BFC2012006
• 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: There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage to the patients blood vessels due to removal without visibility.
• FDA Determined Cause: Component design/selection
• Action: On 10/08/2020, Canon Medical Systems sent a "Urgent: Medical Device Correction" Notification to all affected consignees via Fax. In addition to informing consignees about the correction, Canon as consignees to take the following actions: 1. On a daily basis, prior to the installation of the new cable with the modified routing, please perform the start-up inspection described in the Operation Manual to confirm that the FPD up and down movement operates normally. Additionally, please have available a mobile device which can perform fluoroscopy such as a surgical C-arm device or another catheter inspection/IVR room. 2. If the above event occurs, please stop using the device and contact your Canon service representative. . 3. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility. 4. Please complete and return the attached form and fax it to the toll free number at the top of the form. This form may also be sent via email to RAffairs@us.medical.canon. 5. Thank you for your prompt attention to this matter. If you have any questions, please feel free to contact Terry Schultz Regulatory Affairs Manager at (800) 421-1968 or your local Canon service representative at (800) 521-1968.
• Quantity in Commerce: 14 units
• Distribution: US Nationwide distribution including in the states of LA, CA, CO, WV, GA, NH, FL, PA, WI, MN, ID.
• 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 = OWB and Original Applicant = Canon Medical Systems Corporation; 510(K)s with Product Code = OWB and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION