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
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
O-ARM O2 Imaging System
Lot or serial number
C2202
Model or catalog number
BI-700-02000
Companies
- Manufacturer
-
Medtronic Navigation, Inc. (Littleton)
300 Foster Street
Littleton
01460
Massachusetts
UNITED STATES