Pristina Serena (SenoAxys) recall in Canada: could cause breast injury
In plain language
This recall involves the Pristina Serena (SenoAxys) medical device sold in Canada. It's being recalled because a part of the device may unexpectedly change position during use. This issue could result in injury to the patient's breast.
What to do
- Stop using the product immediately.
- Check model and serial numbers.
- Follow the return or repair steps in the official notice.
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Affected products
Pristina Serena (SenoAxys)
Model: 7201138
Lot: 737211BU3, 739178BU2
Why this matters
Could cause breast injury
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: 737211BU3, 739178BU2
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 7201138
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?
Could cause breast injury
What should consumers do?
Stop using the product immediately. Check model and serial numbers. Follow the return or repair steps in the official notice.
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. Could cause breast injury
When was this product recalled?
This product was recalled on May 31, 2019.
Is the Pristina Serena (SenoAxys) brand affected by this recall?
Yes, Pristina Serena (SenoAxys) products are affected by this recall. This recall involves the Pristina Serena (SenoAxys) medical device sold in Canada. It's being recalled because a part of the device may unexpectedly change position during use. This issue could result in injury to the patient's breast.