Medical device recall in Canada: Biograph mCT-S may delay diagnosis
In plain language
This recall involves Biograph mCT-S, Biograph mCT-S with True V, and Biograph mCT Flow-4R medical devices sold in Canada. They are being recalled because a software issue may cause the system to freeze or abort during use. This could lead to a delay in patient diagnosis. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model/serial numbers if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
Biograph mCT-S (40)
Model: 10248668
Lot: 11044
Biograph mCT-S with True V (40)
Model: 10248671
Lot: 11069
Biograph mCT Flow-4R
Model: 10529159, 10529161
Lot: 11002, 11010
Why this matters
Delay in diagnosis
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: 11002, 11010, 11044, 11069
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 10248668, 10248671, 10529159, 10529161
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?
Delay in diagnosis
What should consumers do?
Stop using the product immediately. Check model/serial numbers if provided. Return, repair, or dispose of it as instructed.
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. Delay in diagnosis
When was this product recalled?
This product was recalled on April 16, 2020.
Is the Biograph brand affected by this recall?
Yes, Biograph products are affected by this recall. This recall involves Biograph mCT-S, Biograph mCT-S with True V, and Biograph mCT Flow-4R medical devices sold in Canada. They are being recalled because a software issue may cause the system to freeze or abort during use. This could lead to a delay in patient diagnosis. Stop using the product and follow the return/repair steps in the official notice.