NEURO|MATE STEREOTACTIC SYSTEM (2020-10-12)

Starting date:

October 12, 2020

Posting date:

October 23, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74159

Last updated:
2020-10-22

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  Reason
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  Affected products

Affected Products

NEURO|MATE STEREOTACTIC SYSTEM

Reason

A problem has been detected relating to the Instructions for Use for Neuroinspire Neuromate Module (H-5630-3016 versions A2-A6) and the Plan Delivery USA Instructions for Use (H-5630-3050-A1). In Section 3.4 "Move to Trajectory" of the Instructions for Use, the bottom right image showing a negative offset is incorrect.

Affected products