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Standard Cranial Reference Array
- Starting date:
- August 17, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15910
Recalled Products
- Standard Cranial Reference Array
Reason
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.
Affected products
A. Standard Cranial Reference Array
Lot or serial number
000000001085709029
9137-07-002-41735
Model or catalog number
41735
Companies
- Manufacturer
- BrainLab AG