SIGNA ARTIST recall in Canada: Missing breast imaging slices
In plain language
This recall involves the SIGNA ARTIST medical device sold in Canada. It's being recalled because it may produce breast images with missing slices. Healthcare professionals should stop using the affected application and follow the steps in the official notice.
What to do
- Stop using the Sagittal vibrant application with asset on the SIGNA ARTIST.
- Check the model and serial numbers of your device.
- Contact GE Healthcare for further instructions.
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Affected products
SIGNA ARTIST
Model: SIGNA ARTIST
Lot: PG45S2000027SC, PG45S2000041SC
Why this matters
Missing slices in breast imaging
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: PG45S2000027SC, PG45S2000041SC
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: SIGNA ARTIST
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?
Missing slices in breast imaging
What should consumers do?
Stop using the Sagittal vibrant application with asset on the SIGNA ARTIST. Check the model and serial numbers of your device. Contact GE Healthcare for further instructions.
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. Missing slices in breast imaging
When was this product recalled?
This product was recalled on September 17, 2021.