Reported Sep 7, 2022 · Ongoing
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- INFX-8000V. For radiographic and fluoroscopic studies and intervention.
- Lot codes and dates
- Model
Alphenix i with software version 8.09.0 or 9.2 and the TFP 1200C FPD
- Model
- Amount recalled
- 16 systems
Where it was sold
- Nationwide
Why it was recalled
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Canon Medical System, USA, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.