Z-0360-2020Class II

Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) -

Name: Z-0360-2020 Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) -
Creator: Canon Medical System, USA, INC.
Published: 2019-02-08
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2019-02-08 / Terminated / root cause: labeling and UDI

FDA source

Canon Medical System, USA, INC. began a recall of Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System... on 2019-02-08. FDA classified it as Class II and gives the reason as "Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0360-2020
Classification: Class II
Status: Terminated
Initiated: 2019-02-08
Posted: 2019-11-12
Terminated: 2022-06-07
Recalling firm: Canon Medical Systems USA, Inc.
Product: Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 02/08/2019, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification to customers via USPS return receipt mail informing them of the potential problem with the Catheterization Table (CAT-870B) may tilt without operator involvement due to accidental liquid spillage. Customers are instructed to: a. Please keep the tableside console and the x-ray detector of the support units covered with sterile caps as stated in the Caution section of the operation manual. The caps are there to prevent liquids from coming into contact with the tableside console and the x-ray detector. b. If an actual event occurs, please push the emergency switch and call your service representative. c. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility. d. Please complete and return the attached form and fax it to the toll free number 877-349-3054. This form may also be sent via email to [email protected]. If customers have any questions regarding this letter, they are free to contact Regulatory Affairs Manager at (800) 421-1968 or their local Representative at (800) 521-1968.
Quantity in commerce: 9 systems
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands.
Product codes and lots: Model CAT-870B D053991 Serial No. Manufacture Date 99D08X2101 October 2008 99D0582039 August 2005 99D0762072 June 2007 99D0852090 May 2008 99D07Y2078 November 2007 99D0812081 January 2008 99D0582042 August 2005 99D0552033 May 2005 D551206 May 2005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0360-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0360-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)