FDAFDA · Food and drugs·Recall number Z-1956-2013
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Published August 21, 2013 · Recall initiated: July 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Navigation, Inc.
- Distributor
- Worldwide Distribution.
- Lot
- Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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