Z-1271-2021Class II

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION...

Name: Z-1271-2021 Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION...
Creator: Canon Medical System, USA, INC.
Published: 2020-12-08
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2020-12-08 / Open, Classified / root cause: design

FDA source

Canon Medical System, USA, INC. began a recall of Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage... on 2020-12-08. FDA classified it as Class II and gives the reason as "System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1271-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-08
Posted: 2021-03-17
Recalling firm: Canon Medical Systems USA, Inc.
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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 01/12/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter via USPS return receipt mail to customers informing them that the catheterization tables may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. Additionally, the manual operation of the tabletop longitudinal or lateral movement will become heavy or hard to move due to the loosening of the bolts. Customers are instructed/informed: a. Should the table top tilt during a procedure before the bolts are replaced and secured, to ensure the safety of the patient, please move the table top to the position of the patients foot and refrain from operating the tabletop as much as possible. Please contact your service representative. b. Share this information with all users and reviewing radiologist as well as clinical engineering, and the biomedical group at their facility. c. Complete and return the attached Response Form and fax it to the toll free number 877-349-3054, or return via email to [email protected] For any questions or assistance, contact Regulatory Affairs Manager at 800-421-1968 or the local service representative at 800-521-1968.
Quantity in commerce: Total of all Systems = 145 systems (U.S.)
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, WA, WI and WV. The countries of Canada, China, Japan, Korea, and Singapore.
Product codes and lots: Table CAT-880B Models: INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BHUP INFX-8000F/AH INFX-8000F/AH INFX-8000F/UU INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BH Table Serial Numbers: 99E1582258 99F18Y2428 99C1482200 99E15Y2271 99F1862406 99G19Z2438 99E1662308 99E1762365 99A1337005 99F1852401 99E1612286 99E1712347 99E1712345 99C14Z2224 99E1592262 99G1972436 System Serial Numbers: AHA1582003 AHC18Y2013 AHA1482001 AHA15Y2005 AHC1862012 BHB19Z2002 AHB1662007 AHB1762010 UUB12X2034 AHC1852011 AHA1612006 AHB1712009 AHB1712008 AHA14Z2002 AHA1592004 BHB1972001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1271-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1269-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-24	2021-03-17
Z-1270-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-24	2021-03-17
Z-1271-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-03-24	2021-03-17

Product code MQB

K081624Class IIInfx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C / cleared 2008-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)