Medtronic Navigation Recalls Framelink Software Version 5.4 for Measurement Discrepancies
Medtronic Navigation is correcting Framelink software version 5.4 due to potential discrepancies between exam images and displayed measurements during surgical planning.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device software defect that could lead to inaccurate surgical planning, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic Navigation, Inc. has initiated a field correction for its Framelink software version 5.4. This software is used on Medtronic Navigation StealthStation S7 and i7 systems, as well as Medtronic Planning Stations, to aid in locating anatomical structures and planning surgical trajectories for open and percutaneous procedures.
The corrective action is being taken because of the potential for a discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use. This issue could affect the accuracy of surgical planning.
The recall affects 572 units distributed worldwide. All kits containing the Framelink software version 5.4 are affected by this corrective action. No specific lot numbers are applicable. Healthcare providers and users of these systems should contact Medtronic Navigation for further instructions on implementing the field correction.
The recalled product
- Product
- StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 572
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)
- Lot number(s): Not applicable
Distribution
Distribution scope not specified by the agency.
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