StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Navigation, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Product Codes/Lot Numbers:
Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1956-2013
Related Recalls
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.