O-ARM O2 Imaging System (2019-11-15)

Starting date:

November 15, 2019

Posting date:

December 13, 2019

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-71863

Last updated: 2019-12-13

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  Reason
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  Affected products

Affected Products

O-ARM O2 Imaging System

Reason

Medtronic has determined through internal testing that there is a potential for navigational inaccuracy when utilizing the O-ARM O2 Imaging System's Auto-Registration Feature, when used in conjunction with an image-guided surgery system for a specific set of O-ARM O2 imaging system serial numbers.

Due to loosening of an internal motor drive belt over extended number of uses, image rotation may occur relative to patient positioning data. Inaccuracy may occur when the o-arm registration information is transferred to an image guided surgery system to be used in navigation, utilizing the rotated images.

 

Affected products