Optima MR360 1.5T recall in Canada: Software defect
In plain language
This recall involves the Optima MR360 1.5T medical device sold in Canada. It's being recalled because incorrect software versions could lead to patient data mismatch, slice mis-registration, or higher thermal doses and localized heating to the patient. In some cases, a patient's hand could be pinched. 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
Optima MR360 1.5T
Model: 5312366 (M50002BB)
Lot: 00000256151HM2, 00000257790HM6
Why this matters
Patient injury from software defect
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: 00000256151HM2, 00000257790HM6
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 5312366 (M50002BB)
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?
Patient injury from software defect
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. Patient injury from software defect
When was this product recalled?
This product was recalled on November 30, 2018.
Is the Optima brand affected by this recall?
Yes, Optima products are affected by this recall. This recall involves the Optima MR360 1.5T medical device sold in Canada. It's being recalled because incorrect software versions could lead to patient data mismatch, slice mis-registration, or higher thermal doses and localized heating to the patient. In some cases, a patient's hand could be pinched. Stop using the product and follow the return/repair steps in the official notice.