---
title: "ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 — FDA record Z-0642-2024 | Is It on Recall"
description: "A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, w"
url: https://isitonrecall.com/recall/fda-device-z-0642-2024-excelsiusgps-flat-panel-fluoroscopy-fixture-kit-part-number-6203-2100/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 — FDA record Z-0642-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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.
- **Classification**: Class I
- **Recalling firm**: Globus Medical, Inc.
- **Quantity**: 9
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0642-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0642-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Montana](https://isitonrecall.com/state/montana/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [Washington](https://isitonrecall.com/state/washington/)

## Dates in the source

- **Report date**: Jan 24, 2024
- **Recall initiation date**: Dec 7, 2023
- **Center classification date**: Jan 18, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0642-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Globus Medical, Inc. records](https://isitonrecall.com/brand/globus-medical-inc/)