CLASS I ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit recalled
Globus Medical is recalling ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, distributed in California, Colorado, Montana, South Carolina, Washington. The recall was initiated on 7 Dec 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0642-2024
- FDA event ID
- 93647
- Recalling firm
- Globus Medical, Audubon, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 7 Dec 2023
- FDA classified
- 18 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Imaging Equipment
Timeline
| 7 Dec 2023 | Recall initiated by company | |
| 18 Jan 2024 | Classified by FDA | +42 days |
| 24 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Where it was distributed
Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
Questions about this recall
Why was it 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.
Which lots 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
Where was it sold?
Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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