Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit Recalled by Globus Medical, Inc. Due to A calibration error associated with the Flat Panel...

Date: December 7, 2023
Company: Globus Medical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Globus Medical, Inc. directly.

Affected Products

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

Quantity: 9

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 5 states: CA, CO, MT, SC, WA

Affected (5 states)Not affected

About Globus Medical, Inc.

Globus Medical, Inc. has 29 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report