STEALTHSTATION S7/S8 (2021-03-09)

Starting date:

March 9, 2021

Posting date:

April 8, 2021

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-75329

Last updated:
2021-04-08

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  Reason
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  Affected products

Affected Products 

A. STEALTHSTATION S7 - CART

B. STEALTHSTATION S8 PREMIUM

Reason

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.

Affected products