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.
Canon is recalling flat panel detectors (TFP-800A) that may display horizontal stripes and fail to recover properly. If an operator works without a clear image, they might accidentally remove a catheter from a blood vessel, causing damage.
The detector may show horizontal stripes and fail to restart correctly. If an operator works without a clear image, they might remove a catheter from a blood vessel, causing damage.
Healthcare professionals using Canon's Alphenix systems with TFP-800A detectors are most at risk. Patients receiving procedures with these faulty detectors could face blood vessel damage.
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.
Verify if the detector displays horizontal stripes or fails to restart properly.
Reach out to Canon Medical for assistance with the specific serial numbers listed in the recall notice.
The detector may show horizontal stripes and fail to restart. If an operator works without a clear image, they might accidentally remove a catheter from a blood vessel, causing damage.
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.
The recall notice does not specify a fix or remedy for the detector issue.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0492-2022 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-0492-2022 from Canon Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
