Globus Medical recalls ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit (part 6203.2100) due to calibration errors causing inaccurate navigation during fluoroscopy procedures.
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.
Globus Medical is recalling its ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit because a calibration error may cause inaccurate navigation during fluoroscopy procedures. This could lead to device misplacement, which might affect surgical outcomes.
The fixture has a calibration error that can cause inaccurate navigation during fluoroscopy. This may result in the surgical device being placed incorrectly, potentially affecting the procedure outcome.
Surgical teams using the ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit for fluoroscopy procedures are likely affected. Patients undergoing surgery with this equipment may be at risk if the navigation becomes inaccurate.
Check for the part number 6203.2100 on the fixture kit. The serial numbers FPFF-0101 through FPFF-0109 indicate the affected units.
Identify the part number 6203.2100 and serial numbers FPFF-0101 to FPFF-0109 on the fixture kit.
The recall is for a calibration error that may cause inaccurate navigation during fluoroscopy, but it does not pose an immediate risk of injury or serious harm in normal use.
Check for the part number 6203.2100 and serial numbers FPFF-0101 through FPFF-0109 on the fixture kit.
The recall does not specify a remedy, so no action is required beyond checking if your fixture matches the part and serial numbers listed.
We’ve drafted a message you can send Globus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0642-2024 — Globus Medical Globus Medical Hello, I own a Globus Medical that is covered by recall Z-0642-2024 from Globus Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
