Medtronic O-arm O2 Surgical Imaging System Recalled for Calibration Errors
Medtronic is recalling 14 O-arm O2 Surgical Imaging Systems because spatial calibration may be erroneous in navigated images, potentially affecting surgical accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (surgical imaging) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Navigation, Inc. is recalling 14 units of the O-arm O2 Surgical Imaging System (Catalog Number BI-700-02000). The recall involves software revisions 4.0.0, 4.0.1, and 4.0.2. The affected systems are identified by specific serial numbers listed in the recall documentation.
The recall is issued because spatial calibration may be erroneous in Stealth Station navigated images. The O-arm system is a multi-dimensional surgical imaging platform designed for use in spine, orthopaedic, and trauma-related surgeries, providing real-time, intra-operative imaging. Erroneous calibration could compromise the accuracy of the navigated images used during these procedures.
The affected units were distributed worldwide, including nationwide in the United States (specifically in Colorado, Kansas, Nebraska, Michigan, Missouri, Ohio, and Washington) and in Switzerland. Healthcare facilities and users of these systems should contact Medtronic Navigation for instructions on how to resolve the issue.
The recalled product
- Product
- Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provid
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Hazard
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software revisions 4.0.0
Distribution
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