Use caution Medical device recall · FDA · Published October 8, 2020

Canon FPD Monitor Recall: Cable Break Risk During Procedures

Canon Medical recalls CAS-930A Flat Panel Monitors used with Infinix-8000C/H systems due to potential cable breakage during procedures, risking patient vessel damage.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0532-2021Medical device Canon Medical ›

Use caution until it’s fixed

There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage to the patients blood vessels due to removal without visibility.

Take action

Contact the company

Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047

✎ GovInfoNow plain-language explainer

Canon Medical is recalling CAS-930A Flat Panel Monitors used with specific angiography systems because a cable might break during procedures. This could cause the exam to stop prematurely and potentially damage blood vessels in patients. Read more at govinfonow.com/recall/64105-canon-fpd-monitor-recall-cable-break-risk-during-procedures.

Source Summary by GovInfoNow · govinfonow.com/recall/64105-canon-fpd-monitor-recall-cable-break-risk-during-procedures · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0532-2021

Cite this page

“Canon FPD Monitor Recall: Cable Break Risk During Procedures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64105-canon-fpd-monitor-recall-cable-break-risk-during-procedures. Based on FDA recall #Z-0532-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0532-2021%22&limit=1).

The FDA announced on October 8, 2020, that Canon Medical System, USA, INC. is recalling the CAS-930A Flat Panel Monitor used with the Canon Interventional Angiography System due to a potential cable break hazard. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

Brand: Canon Medical
Product: CAS-930A Flat Panel Monitor (FPD)
Compatible System: Canon Interventional Angiography System
Model Numbers: Infinix-8000C, Infinix-8000H
Affected Serial Numbers: 1 AFA1662001, 2 AFB1872005, 3 AFB1832003, 4 AFB1872004, 5 AFB1892006, 6 BFA18Y7001, 7 AEA17X2001, 8 AFA1692002, 9 AEB1812002, 10 BFA1932001, 11 BFB1952003, 12 BFB1942002, 13 BFB1972004, 14 BFB1972005, 15 AFB1892007, 16 BEC2032001, 17 BFC2062007, 18 BFC2062008, 19 BHA1992001, 20 BFC2012006
Units Affected: 14

The hazard

According to the FDA, there is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage to the patients blood vessels due to removal without visibility.

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 GE Optima XR220amx Mobile X-Ray System Recall (2026-06-05), GE Optima XR200amx Mobile Radiography System Recall (2026-06-05), and Philips Azurion System Recall (2026-03-31).

How to tell if you have this one

Check if your monitor has the model number CAS-930A and is used with Canon's Infinix-8000C or Infinix-8000H systems. Affected units have specific serial numbers listed in the recall notice.

Brand
Canon Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Monitor Serial Number
Identify if your monitor has one of the listed serial numbers: AFA1662001, AFB1872005, AFB1832003, AFB1872004, AFB1892006, BFA18Y7001, AEA17X2001, AFA1692002, AEB1812002, BFA1932001, BFB1952003, BFB1942002, BFB1972004, BFB1972005, AFB1892007, BEC2032001, BFC2062007, BFC2062008, BHA1992001, BFC2012006

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 11 states.

FDA distribution: “US Nationwide distribution including in the states of LA, CA, CO, WV, GA, NH, FL, PA, WI, MN, ID.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Florida, Georgia, Idaho, Louisiana, Minnesota, New Hampshire, Pennsylvania, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Oct 8, 2020Firm started the recall
Dec 3, 2020FDA classified it Class II
Dec 9, 2020Published in FDA’s Enforcement Report
Dec 6, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Canon Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/64105-canon-fpd-monitor-recall-cable-break-risk-during-procedures">Canon FPD Monitor Recall: Cable Break Risk During Procedures (GovInfoNow)</a>

Where this comes from

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-0532-2021 (October 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0532-2021 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.