FDA Enforcement
Class I
Ongoing
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Recall: Z-0642-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0642-2024
- Event ID
- 93647
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Globus Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- December 7, 2023
- Classification Date
- January 18, 2024
- Address
- 2560 General Armistead Ave, N/A, Audubon, PA, 19403-5214, United States
Description
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
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 Info
UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109
Distribution
Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
Quantity
9