Z-2327-2020Class II

Infinix-8000F with Catheterization Table CAT-850B or CAT-860B -

Name: Z-2327-2020 Infinix-8000F with Catheterization Table CAT-850B or CAT-860B -
Creator: Canon Medical System, USA, INC.
Published: 2020-03-03
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2020-03-03 / Open, Classified / root cause: manufacturing process

FDA source

Canon Medical System, USA, INC. began a recall of 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... on 2020-03-03. FDA classified it as Class II and gives the reason as "Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2327-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-03-03
Posted: 2020-06-09
Recalling firm: Canon Medical Systems USA, Inc.
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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 03/03/20, Urgent Medical Device Correction notices were mailed to Radiology Managers/Directors. To correct this issue, the bolts holding the longitudinal movement of the table will need to be inspected to determine if the bolts are tightened to specification. Recalling firm service representatives will contact customers to set up appointments to inspect bolts. Radiology Managers/Directors were advised of the following: a) Should this problem occur before your appointment with the recalling firm's service representative, please stop using the system and contact the service representative. b) If abnormalities are found operating the table during a procedure, please stop use, and contact the service representative. c) Share this information with all users and reviewing radiologists as well as clinical engineering, and the biomedical group at your facility. d) Complete and return the Customer Reply Form. Additional questions should be directed to (800) 421-1968 or your local service representative (800) 521-1968
Quantity in commerce: 15
Distribution: US Nationwide distribution including in the states of PA, AR, OH, NC, CA, IA, GA, IL, AL, WV, LA, MO, FL, MS, TX, AZ, MA, NJ, MD, NY, NV, OK, WI, PR.
Product codes and lots: Serial Numbers: AGB1692005, AGB17Z2010, AGA1552003, AGB17Y2009, AGB1682004, AGA1492002, AGC1822012, A5C1922001, AGB1712007, AGC1952014, AGB1482001, AGC1822011, BGB1992001, AGC18X2013, AGB16Z2006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2327-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2325-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2326-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2327-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09

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)