Quick summary
Quick summary: Neuromate Stereotactic System.
Public recall detail
Neuromate Stereotactic System
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Neuromate Stereotactic System.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandRenishaw Mayfield Sarl
ProductNeuromate Stereotactic System
IssueMedical devices - Performance
Recall classType I
IdentificationRA-64374
Affected products
ProductNeuromate Stereotactic System
LotAll lots.
Model001.0050
Serial numberAll lots.
DescriptionNeuromate Stereotactic System
Issue
A bug has been detected in the planning software. When loading images, there may be a left/right inversion. Display of image series is flipped after importing a sagittal oriented image series stored using the enhanced Dicom format. Recall start date: July 8, 2022
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesRenishaw Mayfield Sarl 31 Rue Ampere, Chassieu, Rhone, France, 69680
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-64374
Background{}
CompaniesRenishaw Mayfield Sarl 31 Rue Ampere, Chassieu, Rhone, France, 69680
AudiencesHealthcare
Source updated2022-07-18
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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