Recall Z-0532-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
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, bra
| Date | Oct 8, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root 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 cathete |
| Quantity | 14 units |
| Distribution | US Nationwide distribution including in the states of LA, CA, CO, WV, GA, NH, FL, PA, WI, MN, ID. |
| FDA record | Open on fda.gov |