Use cautionMedical device recall · FDA · Published December 20, 2021
Canon Flat Panel Detector TFP-800A: Abnormal Images May Cause Catheter Damage
Canon recalls TFP-800A flat panel detectors used with Alphenix systems due to risk of horizontal stripes causing catheter damage if images fail. Affected units have specific serial numbers.
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.
Take action
Contact the company
📍Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047
“Canon Flat Panel Detector TFP-800A: Abnormal Images May Cause Catheter Damage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61418-canon-flat-panel-detector-tfp-800a-abnormal-images-may-cause. Based on FDA recall #Z-0492-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0492-2022%22&limit=1).
The FDA announced on Dec. 20, 2021, that Canon Medical System, USA, INC. is recalling Flat Panel Detectors due to abnormal images that may prevent system recovery. The agency said the hazard could lead to catheter removal and blood vessel damage.
How to tell if you have it
Brand: Canon Medical
Product: Flat Panel Detector, Model Number: TFP-800A
Used with Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H
Units affected: 8
The hazard
Abnormal images such as horizontal stripes may be displayed and recovery may 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.
Context
GovInfoNow's records show Canon Medical System, USA, INC. has 27 other recalls on record since 2018-04-18. Other recent recalls of similar products include Boston Scientific Imager II Angiographic Catheters Recall (2026-08-24), Getinge Thoracic Catheter Recall (2026-08-07), and Medline Medical Procedure Kits: Catheter Issues Recalled (2026-05-04).
How to tell if you have this one
Check for model TFP-800A with Alphenix systems. Affected units have specific serial numbers listed in the recall notice, including Alphenix system serial numbers like BGC20Y2010 and detector serial numbers like C1B20Y2215.
Brand
Canon Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Detector Status
Verify if the detector displays horizontal stripes or fails to restart properly.
Contact Canon Support
Reach out to Canon Medical for assistance with the specific serial numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Delaware, Florida, Louisiana, Montana, New Jersey, Ohio, West Virginia.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0492-2022 (December 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0492-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.