Device product
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Z-0642-2024
Product summary
- 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
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.