Stryker Navigation System II
Stryker · Model Navigation System II
• Dual articulating arms aid in flexible camera/monitor positioning • Fast, robust industrial PC • Microscope integration • Ability to import flouroscopic and endoscopic images • Accessible I/O panel
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
- RECALL
Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker Navigation System because the settings on the machine were higher than intended. This change led to increased energy directed onto the tip of the Thoracic Pedicle Feeler which caused material degradation where the laser marks exist. There is the potential for the tip of the Thoracic Pedicle Feeler to break.
- RECALL
Product shipped proximate to or past the expiration date listed on the product label.
- RECALL
Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct location, which may result in a potential failure of the arm joint.
- RECALL
Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
- RECALL
Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very slowly.
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Circlip component used to suspend flat panel and navigation arm system may become dislodged.
- RECALL
Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- RECALL
A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
- RECALL
Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.
- RECALL
The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.
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