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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
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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