Recall Z-1271-2021— Canon Medical System, USA, INC.

Name: FDA recall Z-1271-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-08

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2020-12-08. It names one FDA 510(k) clearance: K081624. Product: Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.. Reason: System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2020-12-08
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

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

Reason for recall

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

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