INFINIX & ALPHENIX medical devices recall in Canada: X-ray system error
In plain language
This recall involves INFINIX VC-I-SYSTEM and ALPHENIX INFX-8000C medical devices sold in Canada. They are being recalled because a system error due to a broken power cable can inhibit X-ray fluoroscopy. Healthcare professionals should follow the return steps in the official notice.
What to do
- Stop using the affected medical devices.
- Check model and serial numbers.
- Follow the instructions from Canon Medical Systems Corporation.
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Affected products
INFINIX VC-I-SYSTEM
Model: INFX-8000C/KF, INFX-8000H/KE
Lot: SN KEB1852001, SN KEB1852002, SN KFA17X7001, SN KFB1892001
ALPHENIX INFX-8000C - MAIN UNIT
Model: INFX-8000C
Why this matters
X-ray system error
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: SN KEB1852001, SN KEB1852002, SN KFA17X7001, SN KFB1892001
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: INFX-8000C, INFX-8000C/KF, INFX-8000H/KE
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
X-ray system error
What should consumers do?
Stop using the affected medical devices. Check model and serial numbers. Follow the instructions from Canon Medical Systems Corporation.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. X-ray system error
When was this product recalled?
This product was recalled on September 25, 2020.
Is the INFINIX, ALPHENIX brand affected by this recall?
Yes, INFINIX, ALPHENIX products are affected by this recall. This recall involves INFINIX VC-I-SYSTEM and ALPHENIX INFX-8000C medical devices sold in Canada. They are being recalled because a system error due to a broken power cable can inhibit X-ray fluoroscopy. Healthcare professionals should follow the return steps in the official notice.