CLASS II ONGOING Device recall · Reported 7 Sep 2022 · FDA Enforcement Report
Infx-8000V. For radiographic and fluoroscopic studies recalled
Canon Medical System USA is recalling Infx-8000V. For radiographic and fluoroscopic studies and intervention, distributed nationwide in the US. The recall was initiated on 31 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1666-2022
- FDA event ID
- 90737
- Recalling firm
- Canon Medical System USA, Tustin, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jan 2022
- FDA classified
- 1 Sep 2022
- Reported
- 7 Sep 2022
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 31 Jan 2022 | Recall initiated by company | |
| 1 Sep 2022 | Classified by FDA | +213 days |
| 7 Sep 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Product as listed by the FDA
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Which lots are affected?
Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Canon Medical System USA
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Alphenix Infx-8000C, interventional fluoroscopic x-ray system recalled | Canon Medical System USA | Device Malfunction | Nationwide |
| Device | CLASS II | Alphenix Infx-8000V, interventional fluoroscopic x-ray system recalled | Canon Medical System USA | Device Malfunction | Nationwide |
| Device | CLASS II | Alphenix Infx-8000H, interventional fluoroscopic x-ray system recalled | Canon Medical System USA | Device Malfunction | Nationwide |
| Device | CLASS II | Alphenix Infx-8000F, interventional fluoroscopic x-ray system recalled | Canon Medical System USA | Device Malfunction | Nationwide |
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