FDA Device recall Z-0642-2024
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
- FDA Device
- Class I
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class I recall of ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 by Globus Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0642-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-07 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Globus Medical |
| Distribution | CA, CO, MT, SC, WA |
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.
Identifiers
| code_info | UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0642-2024%22
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