medical Class I Updated 2024-01-24

Globus Medical, Inc. recalls ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number

Recalled Product

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, CO, MT, SC, WA
Lot/Code Info: UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109
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