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Globus Medical, Inc. recalls ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Recalled January 24, 2024 · FDA recall Z-0642-2024 · Globus Medical
Hazard
A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement. · FDA Class I
Units
9
Sold at
Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
Description
A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.
Product
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Manufacturer(s)
Globus Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →