Recall Z-0532-2021— Canon Medical System, USA, INC.

Name: FDA recall Z-0532-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-08

Class II · Terminated

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2020-10-08, terminated 2022-12-06. It names 2 FDA 510(k) clearances: K181804, K152697. 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.. 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..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Terminated
Initiated: 2020-10-08
Terminated: 2022-12-06
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K181804 — Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation·cleared 2018-08-02
K152697 — INFX-8000C, V6.20Toshibamedical Systems Corporation·cleared 2016-01-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.