STEALTHSTATION S7/S8 (2021-03-09)

Date de début :

9 mars 2021

Date d’affichage :

8 avril 2021

Type de communication :

Rappel d'instruments médicaux

Sous-catégorie :

Instruments médicaux

Classification du risque :

Type II

Source :

Santé Canada

Problème :

Instruments médicaux

Public :

Grand public, Professionnels de la santé, Hôpitaux

Numéro d’identification :

RA-75329

Dernière mise à jour:
2021-04-08

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  Raison
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  Produits touchés

Produits Touchés

A. STEALTHSTATION S7 - CART

B. STEALTHSTATION S8 PREMIUM

Raison

Medtronic is updating the Stealthstation S8 Cranial application software to version 1.3.2 and Stealthstation S7 Cranial application software to version 3.1.3 to add two new warning messages pertnaining to accuracy while using the Nexframe Stereotactic System (Nexframe) and the StealthStation auto-registration feature with the O-arm imaging system. Medtronic is providing this software update to impacted StealthStation S7 and StealthStation S8 customers who are users of the Nextframe system. Two warning messages are being added to the software to reinforce messaging from the StealthStation Cranial DBS and Stereotaxy pocket guide. These messages will appear for all Nexframe procedures when using O-arm auto-registration. The first warning message will appear prior to collecting an O-arm scan and will warn the user that movement of the patient during the scan can lead to potential inaccuracy. The second message will appear in the "navigate" task and warn the user to verify their accuracy prior to navigating the O-arm registration.

Produits touchés