ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit — Class I medical device recall Z-0642-2024
Ongoing recall by Globus Medical, Inc., reported 2024-01-24, distributed in CA, CO, MT, SC, WA. A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoros
| Recall number | Z-0642-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Globus Medical, Inc., Audubon, PA, United States |
| Recall initiated | 2023-12-07 |
| Classified | 2024-01-18 |
| Reported by FDA | 2024-01-24 |
| Distributed | CA, CO, MT, SC, WA |
| Countries outside the US | DE, GB |
| Quantity | 9 |
| UPC / GTIN / UDI-DI | 00193982465155 |
| Serial numbers | FPFF-0101, FPFF-0102, FPFF-0103, FPFF-0104, FPFF-0105, FPFF-0106, FPFF-0107, FPFF-0108, FPFF-0109 |
| Model numbers | 6203.2100 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0642-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.