FDAFDA · Food and drugs·Recall number Z-0642-2024
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Published January 24, 2024 · Recall initiated: December 7, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Globus Medical, Inc.
- Distributor
- Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
- Lot
- UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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