Reported Jan 24, 2024 · Ongoing
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Globus Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Globus Medical, Inc. · 2560 General Armistead Ave · Audubon, PA · 19403-5214
Is this the product you have?
- ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
- Lot codes and dates
- UDI-DI 00193982465155 Serial Numbers
FPFF-0101FPFF-0102FPFF-0103FPFF-0104FPFF-0105FPFF-0106FPFF-0107FPFF-0108FPFF-0109
- UDI-DI 00193982465155 Serial Numbers
- Amount recalled
- 9
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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