StealthStation S7 Framelink Software version 5.4. Aid recall: Software Issue
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous…
Why was StealthStation S7 Framelink Software version 5.4. Aid recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.
- Product
- StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous…
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 572
- Distribution
- Worldwide Distribution.
- Recall date
- August 21, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)