CLASS II ONGOING Device recall · Reported 16 Aug 2023 · FDA Enforcement Report
Infx-8000c Xgcp-930aa Table Side Console recalled
Canon Medical System USA is recalling Infx-8000c Xgcp-930aa Table Side Console, Infx-8000c Xgcp-930ba Table Side Console, distributed nationwide in the US. The recall was initiated on 22 Jun 2023 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-2392-2023
- FDA event ID
- 92664
- Recalling firm
- Canon Medical System USA, Tustin, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jun 2023
- FDA classified
- 10 Aug 2023
- Reported
- 16 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 22 Jun 2023 | Recall initiated by company | |
| 10 Aug 2023 | Classified by FDA | +49 days |
| 16 Aug 2023 | 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 C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Where it was distributed
US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA
Nationwide CaliforniaColoradoIllinoisMarylandMinnesotaNew YorkWashington
Questions about this recall
Why was it recalled?
The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.
Which lots are affected?
UDI-DI: 04987670100192. INFX-8000C, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003
Where was it sold?
US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA
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.
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|---|---|---|---|---|---|
| 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 |
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