ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
FDA device recall Z-0642-2024 · posted 2024-01-18 · Open, Classified
Recall details
- Recalling firm
- Globus Medical, Inc.
- 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.
- Action taken
- The firm notified affected customers through URGENT Medical Device Recall Notificatnoi letters dated December 7, 2023. Customers are instructed to immediately return the Flat Panel Fluoroscopy Registration Fixture. For questions related to this recall, please contact Globus Medical Complaint Handling Unit at recall@globusmedical.com.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OLO
- Quantity affected
- 9
- Distribution
- Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
- Date initiated
- 2023-12-07
- Date posted
- 2024-01-18
- Location
- Audubon, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ExcelsiusHub (K211616) | Globus Medical, Inc. | 2021-08-25 |