CLASS II ONGOING Device recall · Reported 28 Feb 2024 · FDA Enforcement Report
The Infx-8000F is designed to take advantage of the latest recalled
Canon Medical System USA is recalling The Infx-8000F is designed to take advantage of the latest technological innovations to, distributed in California, Louisiana. The recall was initiated on 15 Nov 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-1155-2024
- FDA event ID
- 93844
- Recalling firm
- Canon Medical System USA, Tustin, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Nov 2023
- FDA classified
- 16 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 15 Nov 2023 | Recall initiated by company | |
| 16 Feb 2024 | Classified by FDA | +93 days |
| 28 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
Product as listed by the FDA
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality.
Where it was distributed
US: CA, LA
Questions about this recall
Why was it recalled?
VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
Which lots are affected?
UDI-DI: 04987670100208. Serial Number: BGE2292016, BGE2362017
Where was it sold?
US: CA, LA
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.
Other products in this recall event
1 other product · FDA event 93844| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The device is an X-ray system that is capable recalled | Canon Medical System USA | Device Malfunction | CA, LA |
More recalls from Canon Medical System USA
All 51| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Alphenix Infx-8000C/B5 recalled by Canon Medical System USA | Canon Medical System USA | Other | Nationwide |
| 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 |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |