Globus Medical, Inc.: ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

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.

Details from the source

Reason for recall: 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. Distribution: Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK. Quantity: 9 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

UPC codes

00193982465155

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.