FDA-Device2024-01-24Class I
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Globus Medical, Inc.
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.
Sold states
Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
Affected count
9
Manufactured in
2560 General Armistead Ave, N/A, Audubon, PA, United States
Products
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0642-2024Don't want to check this manually?
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