ImageDrive Clinical recall in Canada: misdiagnosis risk
In plain language
This recall involves ImageDrive Clinical medical devices sold in Canada. It's being recalled because a software defect could lead to misdiagnosis. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
ImageDrive Clinical
Model: SYN-0578
Lot: Not applicable.
Why this matters
Misdiagnosis risk
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: Not applicable.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: SYN-0578
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?
Misdiagnosis risk
What should consumers do?
Stop using the product immediately. Check model 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. Misdiagnosis risk
When was this product recalled?
This product was recalled on April 16, 2020.