ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Summary
The FDA issued a Class I for ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 by Globus Medical, Inc.. Reason: A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate nav.
Details
Source
Device Recall
External ID
Z-0642-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Lot/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
Quantity Affected: 9
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.
Distribution
Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-07
Company
Audubon, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Globus Medical, Inc. has 40 FDA actions in our database, including 6 recalls and 34 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Globus Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Globus Medical, Inc. have FDA actions?
Globus Medical, Inc. has 40 FDA actions in our database, including 6 recalls and 34 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0642-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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