Recall Z-2327-2020— Canon Medical System, USA, INC.

Name: FDA recall Z-2327-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-03

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2020-03-03. It names one FDA 510(k) clearance: K081624. Product: Infinix-8000F 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.. Reason: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2020-03-03
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K081624 — INFX-8000F (INFINIX CSI AND INFINIX DPI)Toshiba America Medical Systems, In.C·cleared 2008-06-23

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

Infinix-8000F 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.

Reason for recall

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

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