Z-0492-2022Class II

Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V...

Name: Z-0492-2022 Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V...
Creator: Canon Medical System, USA, INC.
Published: 2021-12-20
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2021-12-20 / Open, Classified / root cause: supplier

FDA source

Canon Medical System, USA, INC. began a recall of Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H on 2021-12-20. FDA classified it as Class II and gives the reason as "Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0492-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-20
Posted: 2022-01-12
Recalling firm: Canon Medical Systems USA, Inc.
Product: Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: On 12/21/2021, the firm notified affected customers via a letter titled, "URGENT: MEDICAL DEVICE CORRECTION." The letter indicated, "Corrective Action: When the new parts become available, your Canon service representative will contact you for an appointment to schedule the installation of the modified x-ray flat panel detector and will install on your system. Requests to Customers: Should this problem occur before the modified x-ray flat panel detector is installed on your system, please attempt computer reboot, and contact your Canon service representative. If you have any questions regarding this matter, please contact your Canon service representative. Please share the contents of this letter with all users and reviewing radiologist as well as clinical engineering or biomedical group at your facility. In order to comply with the FDA record keeping requirement, Canon respectfully requests that the attached form be completed and returned. Please fax it to the toll free number at the top of the form, or return via email to [email protected]. Thank you for your urgent attention to this matter." If you have any questions regarding this letter please contact the Regulatory Affairs Manager at 800.421.1968 or your Canon service representative at 800.521.1968.
Quantity in commerce: 8
Distribution: US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.
Product codes and lots: SID: 30039059, Alphenix System Serial Number: BGC20Y2010, & Flat Panel Detector Serial Number: C1B20Y2215 SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2218; SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2219; SID: 30046247, Alphenix System Serial Number: B1B20Z2001, & Flat Panel Detector Serial Number: C1B20Z2221; SID: 30064041, Alphenix System Serial Number: BGD2172011, & Flat Panel Detector Serial Number: C1B2172234; SID: 30065145, Alphenix System Serial Number: B1E2172002, & Flat Panel Detector Serial Number: C1B2172235; SID: 30058149, Alphenix System Serial Number: B1E2152001, & Flat Panel Detector Serial Number: C1B2152230; SID: 30002089, Alphenix System Serial Number: BHC20Z2003, & Flat Panel Detector Serial Number: C1B20Z2217.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0492-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0492-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-19	2022-01-12

Product code OWB

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)