Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

FDA Recall Z-0642-2024 · Posted 2024-01-18

Recalling FirmGlobus Medical, Inc.
Recall StatusOpen, Classified
Product CodeOLO
Date Initiated2023-12-07
Product Quantity9

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.

Firm Action

The firm notified affected customers through URGENT Medical Device Recall Notificatnoi letters dated December 7, 2023. Customers are instructed to immediately return the Flat Panel Fluoroscopy Registration Fixture. For questions related to this recall, please contact Globus Medical Complaint Handling Unit at [email protected].

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021-08-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑