CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report
Alphenix Infx-8000C/B5 recalled by Canon Medical System USA
Canon Medical System USA is recalling Alphenix Infx-8000C/B5, distributed nationwide in the US. The recall was initiated on 26 Aug 2026 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-0108-2027
- FDA event ID
- 99817
- Recalling firm
- Canon Medical System USA, Tustin, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Aug 2026
- FDA classified
- 7 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 26 Aug 2026 | Recall initiated by company | |
| 7 Oct 2026 | Classified by FDA | +42 days |
| 14 Oct 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
Product as listed by the FDA
Alphenix INFX-8000C/B5
Where it was distributed
US Nationwide distribution in the state of ID.
Questions about this recall
Why was it recalled?
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
Which lots are affected?
Serial no. B5F2532011/UDI: 4987670100192
Where was it sold?
US Nationwide distribution in the state of ID.
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 21 Oct 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 51| 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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