Signa MRI Systems recall in Canada: thermal dose and localized heating risk
In plain language
This recall involves the Signa HDe 1.5T MRI System and Signa Explorer sold in Canada. They are being recalled because incorrect software could lead to higher than expected thermal doses and localized heating for patients. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and serial numbers.
- Return, repair, or dispose of it as instructed.
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Affected products
Signa HDe 1.5T MRI System
Model: S7505KY
Lot: 00000008704YR9, 00000009948YR1, 00000010023YR0, 00000010685YR6, 00000010833YR2, 00000011827YR3
Signa Explorer
Model: 6433266-1
Lot: 3793TA7
Why this matters
Higher than expected thermal dose and localized heating to the patient
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: 00000008704YR9, 00000009948YR1, 00000010023YR0, 00000010685YR6, 00000010833YR2, 00000011827YR3, 3793TA7
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 6433266-1, S7505KY
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?
Higher than expected thermal dose and localized heating to the patient
What should consumers do?
Stop using the product immediately. Check model and serial numbers. 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. Higher than expected thermal dose and localized heating to the patient
When was this product recalled?
This product was recalled on November 30, 2018.
Is the Signa brand affected by this recall?
Yes, Signa products are affected by this recall. This recall involves the Signa HDe 1.5T MRI System and Signa Explorer sold in Canada. They are being recalled because incorrect software could lead to higher than expected thermal doses and localized heating for patients. Stop using the product and follow the return/repair steps in the official notice.