[Recalled] NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared trac
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in t |
|---|---|
| Brand / manufacturer | Northern Digital Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2084-2015 |
| Country of notice | Canada |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 10 June 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
This Class II recall concerns device products distributed in Canada and was recorded by FDA_DEVICE. 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
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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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.