Globus Medical, Inc. is recalling 9 units of the ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100, due to a calibration error. This error occurs when the fixture is used with the ExcelsiusGPS system for fluoroscopy workflows and can lead to inaccurate surgical navigation. Because the navigation may be off, there is a risk that medical devices could be misplaced during a procedure. The affected kits were distributed in California, Colorado, Montana, South Carolina, and Washington, as well as internationally to Germany and the UK.
A calibration error in the fixture can cause the robotic navigation system to display incorrect positioning data to surgeons, which may lead to the improper placement of surgical hardware or implants in a patient.
Contact healthcare provider or manufacturer.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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