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ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

FDA Recall #Z-0642-2024 — Class I — December 7, 2023

Recall #Z-0642-2024 Date: December 7, 2023 Classification: Class I Status: Ongoing

Product Description

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

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.

Recalling Firm

Globus Medical, Inc. — Audubon, PA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

9

Distribution

Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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