ExcelsiusGPS surgical navigation system calibration error may cause device misplacement
Globus Medical is recalling the ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit due to a calibration error that may cause inaccurate navigation and device misplacement during surgery. Nine units are distributed across select US states and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class I device recall for surgical navigation equipment. Calibration error poses potential for serious patient harm through device misplacement in surgery. No reported injuries or illnesses. Classified as High (3) per rubric criterion: risk-of-harm products without reported injury.
Plain-English summary
Globus Medical, Inc. has issued a Class I recall for the ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100. The recalled units are identified by serial numbers FPFF-0101 through FPFF-0109.
A calibration error in the Flat Panel Fluoroscopy Fixture may cause inaccurate navigation during fluoroscopy-guided surgical procedures when used with the ExcelsiusGPS system. This inaccuracy could result in improper placement of surgical devices, potentially affecting surgical outcomes.
Nine units have been distributed domestically to California, Colorado, Montana, South Carolina, and Washington, with additional units distributed to Germany and the United Kingdom.
Healthcare facilities with affected units should immediately cease use and contact Globus Medical for instructions on replacement or remediation.
The recalled product
- Product
- ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
- Manufacturer
- Globus Medical, Inc.
- Affected units
- 9
Distribution
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