Device product

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

Z-0642-2024

December 07, 2023

Class I

Product summary

Firm: Globus Medical, Inc.
Event: Event 93647
Status: Ongoing
Classification: Class I
Quantity: 9
Official record key: device-enforcement:Z-0642-2024

Official wording

Reason: 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.

Code information: UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109

Distribution pattern: Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.