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[Recalled] Standard Cranial Reference Array

recall health-canada medical-devices canada

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductStandard Cranial Reference Array
CategoryMedical devices
Issuing authorityHealth Canada — Medical Devices
Reference48484
Country of noticeCanada
Authority classificationType II
Notice date26 November 2012

Why it was recalled

According to the Health Canada — Medical Devices notice, the identified hazard is: There are specific pairs of arrays that might add an inaccuracy of more than 1 mm to the registration result during the exchange due to the combination of their tolerance limits. This effect could potentially cause an inaccurate display of instruments by the navigation system in the region of interest, compared to the actual patient anatomy.

This recall concerns Medical devices products distributed in Canada and was recorded by Health Canada — Medical Devices. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Review the official notice to confirm whether your unit is affected.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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