ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit recall
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Why was ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109
- Product
- ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
- Recalling firm
- Globus Medical, Inc.
- Quantity
- 9
- Distribution
- Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
- Recall date
- January 24, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)