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.
- Company
- Canon Medical System, Usa, Inc.
- Recall Initiated
- October 8, 2020
- Terminated
- December 6, 2022
- Recall Number
- Z-0532-2021
- Quantity
- 14 units
- Firm Location
- Tustin, CA
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.
Distribution
US Nationwide distribution including in the states of LA, CA, CO, WV, GA, NH, FL, PA, WI, MN, ID.
Lot / Code Info
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
Root Cause
Component design/selection
Action Taken
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.